{
  "slug": "surgery-fistula",
  "question": "Can an anal fistula heal without surgery, or is surgery always needed?",
  "shortTitle": "Anal Fistula: Heal Without Surgery?",
  "clinicalQuestion": "In adults with a cryptoglandular anal fistula (fistula-in-ano), does non-surgical management (e.g., antibiotics, observation, seton drainage alone, or other conservative measures) achieve fistula closure and prevent recurrence compared with surgical treatment (fistulotomy, LIFT, advancement flap, or other operative repair)?",
  "pico": {
    "population": "Adults with a confirmed anal fistula (fistula-in-ano), excluding those with Crohn's-related fistulas unless specified",
    "intervention": "Non-surgical or conservative management (antibiotics, seton drainage without definitive surgery, watchful waiting, or minimally invasive non-excisional treatments)",
    "comparator": "Surgical treatment (fistulotomy, LIFT procedure, advancement flap, or other operative fistula repair)",
    "outcomes": [
      "Fistula healing or closure rate",
      "Recurrence rate at 12 months",
      "Time to complete healing",
      "Fecal incontinence rate",
      "Need for repeat or salvage surgery",
      "Persistent discharge or abscess recurrence"
    ]
  },
  "category": "anorectal",
  "relatedConditions": [
    "anal-fistula",
    "perianal-abscess",
    "crohns-disease"
  ],
  "relatedTreatments": [],
  "relatedEvidence": [],
  "bottomLine": {
    "verdict": "In adults with a typical (cryptoglandular) anal fistula, the little evidence available suggests the tunnel usually does not close on its own, and non-surgical options may work less reliably than surgery.",
    "detail": "Only two studies actually address this exact comparison, and both are weak: one is an expert opinion piece with no original data, and the other combines older low-quality studies rather than testing people directly. One reports that fistulas rarely heal by themselves, and the other found a non-surgical fistula plug failed more often than surgery. Because no trial has properly tested this, and other smaller studies don't all agree, this is a signal of possible harm from relying on non-surgical treatment, not a settled answer.",
    "studyIds": [
      "pmid:23179514",
      "pmid:22964807"
    ]
  },
  "strength": {
    "level": "very-low",
    "why": "Only observational evidence addresses this question (2 studies). The studies disagree with one another, so the overall certainty is lower than any single one of them.",
    "override": null
  },
  "direction": {
    "level": "harm-signal",
    "why": "2 studies reported harm or tissue damage, including laboratory evidence.",
    "override": null
  },
  "counts": {
    "recordsRetrieved": 114,
    "recordsScreened": 114,
    "included": 80,
    "rcts": 1,
    "systematicReviews": 8,
    "observational": 29,
    "participants": 12241,
    "yearFrom": 1979,
    "yearTo": 2026,
    "registeredTrialsWithoutResults": 0
  },
  "excluded": [],
  "outcomes": [
    {
      "name": "Fistula healing or closure rate",
      "status": "possible-harm",
      "note": "The two studies that directly address adults with this type of fistula both raise concern: one states these fistulas rarely close on their own, and the other found a non-surgical fistula plug closed the fistula less often than surgery did.",
      "studyIds": [
        "pmid:23179514",
        "pmid:22964807"
      ]
    },
    {
      "name": "Recurrence rate at 12 months",
      "status": "insufficient",
      "note": "The meta-analysis reported overall recurrence (fistula coming back) but not specifically at the 12-month mark, so there isn't a clean answer for this exact timepoint.",
      "studyIds": [
        "pmid:22964807"
      ]
    },
    {
      "name": "Time to complete healing",
      "status": "not-studied",
      "note": "Neither of the two studies that directly address this question reported how long healing took with non-surgical versus surgical treatment.",
      "studyIds": []
    },
    {
      "name": "Fecal incontinence rate",
      "status": "no-improvement",
      "note": "The meta-analysis found no significant difference in loss of bowel control between the non-surgical fistula plug and surgery, so avoiding surgery did not appear to lower this particular risk.",
      "studyIds": [
        "pmid:22964807"
      ]
    },
    {
      "name": "Need for repeat or salvage surgery",
      "status": "possible-harm",
      "note": "Because the non-surgical fistula plug failed more often than surgery, and a review describes most fistulas eventually needing an operation, non-surgical treatment appears more likely to be followed by a later surgery.",
      "studyIds": [
        "pmid:23179514",
        "pmid:22964807"
      ]
    },
    {
      "name": "Persistent discharge or abscess recurrence",
      "status": "not-studied",
      "note": "Neither of the two studies that directly address this question measured ongoing discharge or repeat abscesses after treatment.",
      "studyIds": []
    }
  ],
  "benefits": [],
  "limitations": [
    {
      "text": "Only two sources address this comparison in adults with cryptoglandular anal fistula: a narrative review (Chirurg 2012) that makes general clinical statements with no original patient data, study design, or numbers, and a meta-analysis of 428 patients (Saudi Med J 2012) that found a fistula plug had higher recurrence than conventional surgery (62.1% vs 47%). Neither compares true non-surgical management, such as antibiotics or watchful waiting, with surgery: the review gives no data at all, and the meta-analysis compares two procedures (plug versus surgery), not surgery versus no treatment.",
      "studyIds": [
        "pmid:23179514",
        "pmid:22964807"
      ]
    },
    {
      "text": "One of the two key sources is a narrative review with no original patient data, numbers, or methodology — it states a clinical impression rather than measured results.",
      "studyIds": [
        "pmid:23179514"
      ]
    },
    {
      "text": "The other key source is a meta-analysis of studies comparing a fistula plug with conventional surgery, rated low quality overall; the abstract does not report on differences between the included studies (heterogeneity), their risk of bias, or how long patients were followed.",
      "studyIds": [
        "pmid:22964807"
      ]
    },
    {
      "text": "Most of the 80 related studies found in this search involve children, people with Crohn's disease, or other kinds of fistula entirely (such as rectovaginal or rectourethral fistula after prostate surgery), so they cannot be used to answer this question for adults with a standard anal fistula.",
      "studyIds": [
        "pmid:40983150",
        "pmid:27663698",
        "pmid:24436656",
        "pmid:28916253",
        "pmid:27466166"
      ]
    },
    {
      "text": "Smaller separate case series of non-surgical treatments (such as chemical or plug-based methods) report healing in roughly half to three-quarters of patients, which conflicts with the harm signal from the two directly relevant studies — this disagreement is part of why overall certainty is rated very low.",
      "studyIds": [
        "pmid:33787391",
        "pmid:31535505",
        "pmid:22476123"
      ]
    }
  ],
  "risks": [
    {
      "text": "A combined analysis of earlier studies found that a non-surgical fistula plug was followed by the fistula coming back more often than with surgery (about 62 out of 100 people versus about 47 out of 100).",
      "studyIds": [
        "pmid:22964807"
      ],
      "severity": "serious"
    },
    {
      "text": "A review of fistula treatment states these tunnels usually do not close by themselves, meaning ongoing infection, drainage, or abscess can persist if surgery is delayed or avoided.",
      "studyIds": [
        "pmid:23179514"
      ],
      "severity": "serious"
    }
  ],
  "whyPeopleTryIt": [
    {
      "text": "Surgery near the anal sphincter (the muscle ring that controls bowel movements) sounds frightening, and people worry about losing control of bowel movements afterward."
    },
    {
      "text": "Non-surgical options like antibiotics, chemical solutions, or a plug are marketed as a way to fix the problem without an operation or anaesthesia."
    },
    {
      "text": "Some people hope the fistula will simply close on its own if they keep the area clean and wait."
    },
    {
      "text": "Avoiding surgery means avoiding time off work, a hospital visit, and the cost of an operation."
    }
  ],
  "keyStudies": [
    "pmid:22964807",
    "pmid:23179514",
    "pmid:19143149",
    "pmid:33787391",
    "pmid:31535505",
    "pmid:30187327"
  ],
  "studies": [
    {
      "id": "pmid:42221001",
      "pmid": "42221001",
      "doi": "10.3389/fped.2026.1789225",
      "nctId": null,
      "pmcid": "PMC13219376",
      "title": "Age-stratified management of pediatric perianal abscesses: a proposed framework integrating the \"Developmental Healing Axis\"",
      "firstAuthor": "Yuan",
      "multipleAuthors": true,
      "journal": "Front Pediatr",
      "year": 2026,
      "design": "narrative-review",
      "n": null,
      "nField": "not-reported",
      "population": "children with perianal abscesses",
      "intervention": "conservative treatment (antibiotics and watchful waiting) versus surgical drainage",
      "comparator": "surgical incision and drainage versus conservative management, varying by age",
      "primaryOutcome": "fistula formation and recovery after abscess treatment",
      "result": "conservative strategies often effective in infants/young children, while surgical drainage in older children carries more fistula risk",
      "resultDirection": "mixed",
      "quality": "very-low",
      "qualityWhy": "this is a narrative review of pediatric abscesses (not established fistulas) with no systematic methodology or pooled data reported.",
      "directness": "indirect",
      "limitations": "abstract describes a conceptual review of abscess management in children, not a study of existing fistulas healing without surgery, and identifies its own evidence gaps needing future research.",
      "followUp": "",
      "plainFinding": "Conservative care may work in young children.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/42221001/",
      "sourceText": "Pediatric perianal abscesses represent a frequent yet underrecognized condition that poses diagnostic and therapeutic challenges due to tissue fragility and age-dependent healing dynamics. This review synthesizes current evidence on the epidemiology, pathophysiology, and management of pediatric perianal abscesses to provide a conceptual basis for clinical decision-making. Surgical interventions such as incision and drainage offer rapid symptom relief but may increase the risk of fistula formation, particularly in older children. In contrast, conservative strategies including antibiotic therapy and observation are often effective in infants and young children, reflecting their superior regenerative capacity. Age-related differences in immune response, microbiota composition, and glandular anatomy contribute to variations in disease progression and healing outcomes. By integrating data from recent studies and clinical guidelines, this review highlights the importance of individualized, age-specific management to optimize recovery, minimize recurrence, and prevent fistula development. Furthermore, it identifies gaps in current evidence and underscores the need for standardized treatment protocols and future research into predictive and microbiome-related factors influencing disease course.",
      "provenance": [
        {
          "field": "population",
          "quote": "Pediatric perianal abscesses represent a frequent yet underrecognized condition"
        },
        {
          "field": "intervention",
          "quote": "Surgical interventions such as incision and drainage offer rapid symptom relief but may increase the risk of fistula formation, particularly in older children."
        },
        {
          "field": "comparator",
          "quote": "conservative strategies including antibiotic therapy and observation are often effective in infants and young children, reflecting their superior regenerative capacity"
        },
        {
          "field": "primaryOutcome",
          "quote": "minimize recurrence, and prevent fistula development"
        },
        {
          "field": "result",
          "quote": "Surgical interventions such as incision and drainage offer rapid symptom relief but may increase the risk of fistula formation, particularly in older children. In contrast, conservative strategies including antibiotic therapy and observation are often effective in infants and young children"
        }
      ]
    },
    {
      "id": "pmid:41578630",
      "pmid": "41578630",
      "doi": "10.12659/MSM.949712",
      "nctId": null,
      "pmcid": "PMC12849397",
      "title": "Predictors of Recurrence in Pediatric Perianal Abscess and Fistula-In-Ano: Insights From a 5-Year Surgical Cohort Study",
      "firstAuthor": "Borkowski",
      "multipleAuthors": true,
      "journal": "Med Sci Monit",
      "year": 2026,
      "design": "retrospective",
      "n": 108,
      "nField": "reported",
      "population": "children aged 0 to 17 with perianal abscess or fistula-in-ano",
      "intervention": "surgical incision and drainage, with some having an existing fistula-in-ano found during surgery",
      "comparator": "patients without a fistula-in-ano found during initial surgery",
      "primaryOutcome": "recurrence of abscess or fistula after surgical treatment",
      "result": "having a fistula-in-ano found at the first surgery predicted higher fistula recurrence (31.6% vs 10.1%), while abscess recurrence was not significantly different; antibiotics, abscess size, and symptom duration did not predict recurrence",
      "resultDirection": "mixed",
      "quality": "low",
      "qualityWhy": "this is a retrospective single-center review of only surgically treated patients without a non-surgical comparison group, so it can't show whether surgery is needed.",
      "directness": "indirect",
      "limitations": "Retrospective design, all patients received surgery as primary management, and ultrasound diagnosis of fistula was often inconclusive (67 cases with no definitive conclusion).",
      "followUp": "",
      "plainFinding": "Prior fistula predicts recurrence after surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/41578630/",
      "sourceText": "BACKGROUND Perianal abscess (PA) and fistula-in-ano (FIA) are common in children, particularly infants. Despite their frequency, their pathophysiology, diagnostic accuracy, and optimal treatment remain debated. This study aimed to evaluate recurrence rates after surgical treatment of PA and FIA and identify clinical factors associated with fistula formation, including ultrasound findings, antibiotic therapy, abscess size, and symptom duration in otherwise healthy pediatric patients. MATERIAL AND METHODS We retrospectively reviewed 108 pediatric patients (0-17 years) treated surgically for PA and/or FIA between January 2019 and February 2024 at a tertiary care center. Inclusion criteria were PA diagnosis and incision and drainage as primary management. Data included intraoperative findings, recurrence, antibiotic use, ultrasound results, symptom duration, and abscess size (infants only). RESULTS Intraoperative FIA was identified in 19/108 patients (17.8%). Overall recurrence occurred in 29 patients (26.9%). Recurrence of PA was more frequent in those with initial FIA (36.8%) than without (24.7%) but was not significant (P>0.05). However, FIA recurrence was significantly higher in patients with initial FIA (31.6% vs 10.1%, P=0.024). Among 99 patients undergoing ultrasound, diagnostic accuracy for PA was 100%. Regarding FIA, there were 3 false negatives and 5 false positives; in 67 cases, no definitive conclusion was provided. Antibiotic therapy, abscess size, and symptom duration showed no significant association with recurrence or FIA development. CONCLUSIONS Initial intraoperative detection of FIA significantly predicts future recurrence. Antibiotic use, symptom duration, and abscess size were not predictive. Findings highlight the need for improved diagnostic tools and standardized management protocols in pediatric PA and FIA.",
      "provenance": [
        {
          "field": "n",
          "quote": "We retrospectively reviewed 108 pediatric patients (0-17 years) treated surgically for PA and/or FIA"
        },
        {
          "field": "population",
          "quote": "pediatric patients (0-17 years) treated surgically for PA and/or FIA between January 2019 and February 2024"
        },
        {
          "field": "intervention",
          "quote": "Inclusion criteria were PA diagnosis and incision and drainage as primary management."
        },
        {
          "field": "comparator",
          "quote": "Recurrence of PA was more frequent in those with initial FIA (36.8%) than without (24.7%)"
        },
        {
          "field": "primaryOutcome",
          "quote": "This study aimed to evaluate recurrence rates after surgical treatment of PA and FIA and identify clinical factors associated with fistula formation"
        },
        {
          "field": "result",
          "quote": "FIA recurrence was significantly higher in patients with initial FIA (31.6% vs 10.1%, P=0.024). Among 99 patients undergoing ultrasound, diagnostic accuracy for PA was 100%."
        }
      ]
    },
    {
      "id": "pmid:41047078",
      "pmid": "41047078",
      "doi": "10.1016/j.clinre.2025.102706",
      "nctId": null,
      "pmcid": null,
      "title": "Does antibiotic therapy for anal abscess reduce the risk of fistula surgery? A retrospective study",
      "firstAuthor": "Alam",
      "multipleAuthors": true,
      "journal": "Clin Res Hepatol Gastroenterol",
      "year": 2025,
      "design": "retrospective",
      "n": 109,
      "nField": "reported",
      "population": "adults with a first-time perianal abscess treated by incision",
      "intervention": "antibiotic therapy given after incision",
      "comparator": "incision alone without antibiotics",
      "primaryOutcome": "rate of patients requiring fistula surgery and/or experiencing abscess recurrence",
      "result": "absence of antibiotic therapy after incision was linked to higher recurrence; 18% of incision-alone patients had recurrence",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This was a small retrospective study with only univariate analysis and no multivariate analysis due to insufficient data, so the finding is weak.",
      "directness": "indirect",
      "limitations": "Retrospective design, multivariate analysis not conducted due to insufficient data, and the study looked at abscess patients rather than confirmed fistula patients.",
      "followUp": "approximately 30 months",
      "plainFinding": "Antibiotics after incision reduced recurrence",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/41047078/",
      "sourceText": "BACKGROUND: Management of first-time perianal abscesses remains controversial. While the French school of proctology systematically investigates fistulas, other approaches advocate simple incision, given that over 60 % of patients do not develop recurrence. The role of post-incision antibiotic therapy is also debated. This study aimed at evaluating our department's approach to managing first perianal abscesses and identifying predictive factors for recurrence. METHODS: We retrospectively included all patients presenting in 2019 with a first perianal abscess treated by incision under local anesthesia, with or without antibiotic therapy post-incision. Patients with evident fistulas underwent surgery. Recurrence was defined as a new abscess or purulent opening. The primary outcome was the rate of patients requiring fistula surgery and/or experiencing abscess recurrence; secondary outcomes included identification of recurrence predictors. RESULTS: Among the 336 patients who consulted for an abscess, 109 were included. Among 109 patients (mean age 43 ± 13 years; 74 % male), 55 had incision alone, and 54 underwent fistula surgery. The mean follow-up for patients with incision alone was approximately 30 months, during which 18 % (10 patients) experienced abscess recurrence. Univariate logistic regression analysis revealed smoking and absence of antibiotic therapy post-incision as predictive of recurrence with (OR 0.44) were predictive of recurrence. Gender, age, BMI, diabetes, Crohn's disease, HIV infection, prior NSAID use, and abscess location were not predictive. Multivariate analysis was not conducted due to insufficient data. CONCLUSION: This study demonstrates that 41 % of patients who underwent incision for a first perianal abscess did not experience recurrence during the follow-up period. Additionally, the administration of antibiotic therapy post-incision was associated with a reduced likelihood of recurrence. However, randomized trials are warranted to validate these findings and specify the optimal antibiotic regimen.",
      "provenance": [
        {
          "field": "n",
          "quote": "Among 109 patients (mean age 43 ± 13 years; 74 % male), 55 had incision alone, and 54 underwent fistula surgery."
        },
        {
          "field": "population",
          "quote": "We retrospectively included all patients presenting in 2019 with a first perianal abscess treated by incision under local anesthesia"
        },
        {
          "field": "intervention",
          "quote": "with or without antibiotic therapy post-incision"
        },
        {
          "field": "comparator",
          "quote": "The role of post-incision antibiotic therapy is also debated."
        },
        {
          "field": "primaryOutcome",
          "quote": "The primary outcome was the rate of patients requiring fistula surgery and/or experiencing abscess recurrence"
        },
        {
          "field": "result",
          "quote": "absence of antibiotic therapy post-incision as predictive of recurrence with (OR 0.44) were predictive of recurrence"
        },
        {
          "field": "result",
          "quote": "during which 18 % (10 patients) experienced abscess recurrence"
        },
        {
          "field": "followUp",
          "quote": "The mean follow-up for patients with incision alone was approximately 30 months"
        }
      ]
    },
    {
      "id": "pmid:40983150",
      "pmid": "40983150",
      "doi": "10.1016/j.jpedsurg.2025.162691",
      "nctId": null,
      "pmcid": null,
      "title": "Management of Perianal Abscesses in Infants: A Systematic Review From the APSA Outcomes and Evidence-Based Practice Committee",
      "firstAuthor": "Acker",
      "multipleAuthors": true,
      "journal": "J Pediatr Surg",
      "year": 2025,
      "design": "systematic-review",
      "n": null,
      "nField": "not-reported",
      "population": "infants with perianal abscess or anal fistula",
      "intervention": "non-operative care (hygiene, sitz baths, antibiotics) or incision and drainage of abscess",
      "comparator": "direct surgical treatment of the fistula (e.g., upfront fistulotomy)",
      "primaryOutcome": "whether the perianal disease resolved or came back, including fistula development",
      "result": "About 37.5% of non-operative treatment failed initially; recurrence was about 21% after non-operative care and 24% after incision and drainage; fistula developed in about 21% after non-operative care versus 20% after drainage; recurrence after surgery for the fistula itself was about 7%",
      "resultDirection": "mixed",
      "quality": "low",
      "qualityWhy": "It pools findings from many small, lower-quality studies (level 3-4 evidence) in infants, so the numbers are rough estimates rather than strong proof.",
      "directness": "indirect",
      "limitations": "Includes only level 3-4 studies, time to resolution varied widely, and findings are specific to infants rather than the general population with anal fistula.",
      "followUp": "",
      "plainFinding": "Recurrence common whether treated with surgery or not.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/40983150/",
      "sourceText": "BACKGROUND: Management of infant perianal disease, including perianal abscess and fistula-in- ano (FIA), remains controversial. There is lack of consensus regarding the risks and benefits of operative and non-operative approaches. METHODS: The American Pediatric Surgical Association Outcomes and Evidence Based Practice Committee created a priori consensus-based questions regarding the various approaches to management of perianal abscess and FIA in infants. A comprehensive search strategy was created, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used to identify and review relevant articles and answer the established questions. RESULTS: Over 2460 titles and abstracts were screened to identify 31 manuscripts describing the expected course of perianal disease when managed with nonoperative management (NOM) strategies (such as hygiene, sitz baths, and systemic antibiotics), operative intervention for abscess only (incision and drainage (I&D)) or direct surgical management of the FIA (e.g. upfront fistulotomy). Initial failure of NOM is approximately 37.5 %. Recurrence rate after initial success with NOM or I&D is approximately 21 % and 24 %, respectively. The rate of FIA development is approximately 21 % after NOM and 20 % after I&D. Recurrence after operative management of FIA, regardless of approach, is 7 %. Time to complete resolution varies widely and does not appear to differ based on treatment strategy. CONCLUSIONS: Both operative and non-operative approaches can be safely used in the management of perianal abscess and FIA but recurrence is common regardless of approach. Risks and benefits of each approach should be considered on a case-by-case basis. TYPE OF STUDY: Systematic Review of level 3-4 studies. LEVEL OF EVIDENCE: Level 4.",
      "provenance": [
        {
          "field": "population",
          "quote": "Management of infant perianal disease, including perianal abscess and fistula-in- ano (FIA)"
        },
        {
          "field": "intervention",
          "quote": "nonoperative management (NOM) strategies (such as hygiene, sitz baths, and systemic antibiotics), operative intervention for abscess only (incision and drainage (I&D))"
        },
        {
          "field": "comparator",
          "quote": "direct surgical management of the FIA (e.g. upfront fistulotomy)"
        },
        {
          "field": "primaryOutcome",
          "quote": "Recurrence rate after initial success with NOM or I&D is approximately 21 % and 24 %, respectively."
        },
        {
          "field": "result",
          "quote": "Initial failure of NOM is approximately 37.5 %. Recurrence rate after initial success with NOM or I&D is approximately 21 % and 24 %, respectively. The rate of FIA development is approximately 21 % after NOM and 20 % after I&D. Recurrence after operative management of FIA, regardless of approach, is 7 %."
        },
        {
          "field": "n",
          "quote": "31 manuscripts describing the expected course of perianal disease"
        }
      ]
    },
    {
      "id": "pmid:40926129",
      "pmid": "40926129",
      "doi": "10.1007/s00384-025-04991-x",
      "nctId": null,
      "pmcid": "PMC12420708",
      "title": "Less combination therapy and more fistulotomy in perianal fistulizing Crohn's disease in the elderly",
      "firstAuthor": "Arjafallah Goulet",
      "multipleAuthors": true,
      "journal": "Int J Colorectal Dis",
      "year": 2025,
      "design": "retrospective",
      "n": 30,
      "nField": "reported",
      "population": "People over 60 with Crohn's disease who needed first-time surgery for an anal fistula, compared with matched younger patients",
      "intervention": "Less intensive combined drug therapy and more simple fistula-opening surgery (fistulotomy) in older patients",
      "comparator": "More intensive combined drug therapy and more sphincter-sparing surgery in younger matched patients",
      "primaryOutcome": "Whether the anal fistula closed after treatment",
      "result": "Fistula closure rates were about the same in older and younger patients even though older patients got less aggressive drug therapy and more fistulotomies",
      "resultDirection": "no-benefit",
      "quality": "low",
      "qualityWhy": "This is a retrospective, matched comparison of surgical patients with Crohn's-related fistulas, not a trial testing surgery versus no surgery, so it can't show whether fistulas heal without surgery.",
      "directness": "indirect",
      "limitations": "Retrospective design, small elderly group (n=30), matched rather than randomized comparison, and all patients underwent surgery so there is no non-surgical comparison group.",
      "followUp": "",
      "plainFinding": "Similar healing with less aggressive treatment in elderly",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/40926129/",
      "sourceText": "BACKGROUND AND AIMS: This study aimed to describe Crohn's disease perianal fistulizing lesions in patients undergoing surgery over 60 years to compare clinical presentation, management and outcomes with those observed in younger patients. METHODS: Between January 2012 and December 2022, all patients over 60 years old who underwent a first surgical intervention for anal fistula at two medical centers were included. For each patient included, two younger patients who underwent the same surgical procedure during the same period in the same centers were matched for comparison. RESULTS: Among 536 patients who underwent surgery, 6% (n = 30) aged over 60 years at first surgery were included. Compared with their younger counterparts, older patients had: i) a diagnosis of Crohn's disease and fistula more often in the same year: 63% vs 26%, p = 0.001; ii) combined therapy and anti-TNF alpha optimization less often (p = 0.0002 and p = 0.0001); iii) fewer surgical interventions: 3 vs 4.5, p = 0.008; iv) sparing surgery less frequently: 30% vs 58%, p = 0.01; v) fistulotomy more often: 27% vs 5%, p = 0.003. The rates of anal fistula closure were comparable between the two groups: 60% vs 62%, p = 0.93. CONCLUSION: Synchronous diagnosis of anal fistula and Crohn's disease within the first year of care is not uncommon after 60 years of age, suggesting that Crohn's disease should not be overlooked in older individuals developing an anal fistula. Despite receiving less aggressive medical management due to age-related factors, elderly patients achieved similar fistula closure rates, through a more pragmatic surgical approach, including more fistulotomies in selected patients.",
      "provenance": [
        {
          "field": "n",
          "quote": "6% (n = 30) aged over 60 years at first surgery were included"
        },
        {
          "field": "population",
          "quote": "all patients over 60 years old who underwent a first surgical intervention for anal fistula at two medical centers were included"
        },
        {
          "field": "comparator",
          "quote": "two younger patients who underwent the same surgical procedure during the same period in the same centers were matched for comparison"
        },
        {
          "field": "intervention",
          "quote": "combined therapy and anti-TNF alpha optimization less often (p = 0.0002 and p = 0.0001); iii) fewer surgical interventions: 3 vs 4.5, p = 0.008; iv) sparing surgery less frequently: 30% vs 58%, p = 0.01; v) fistulotomy more often: 27% vs 5%, p = 0.003"
        },
        {
          "field": "primaryOutcome",
          "quote": "The rates of anal fistula closure were comparable between the two groups"
        },
        {
          "field": "result",
          "quote": "The rates of anal fistula closure were comparable between the two groups: 60% vs 62%, p = 0.93"
        }
      ]
    },
    {
      "id": "pmid:40585484",
      "pmid": "40585484",
      "doi": "10.3389/fsurg.2025.1572049",
      "nctId": null,
      "pmcid": "PMC12202503",
      "title": "Treatment of perianal abscess and anal fistula in infants: a systematic review",
      "firstAuthor": "Chen",
      "multipleAuthors": true,
      "journal": "Front Surg",
      "year": 2025,
      "design": "systematic-review",
      "n": 1770,
      "nField": "reported",
      "population": "infants with perianal abscess or anal fistula",
      "intervention": "conservative (non-surgical) treatment",
      "comparator": "surgical treatment",
      "primaryOutcome": "cure rate and recurrence of abscess or fistula",
      "result": "similar cure rates: 75.2% cured with conservative treatment vs 73.4% cured with surgery",
      "resultDirection": "no-benefit",
      "quality": "low",
      "qualityWhy": "it pools 18 retrospective studies without randomization, so differences between groups could be due to other factors.",
      "directness": "indirect",
      "limitations": "all included studies were retrospective; the abstract does not describe randomization or control for confounding factors between conservative and surgical groups",
      "followUp": "",
      "plainFinding": "Similar healing with or without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/40585484/",
      "sourceText": "INTRODUCTION: The optimal treatment approach for perianal abscess (PA) and fistula-in-ano (FIA) in infants remains a subject of debate. MATERIAL AND METHODS: A thorough literature search was conducted across multiple databases, including Embase, PubMed, Web of Science, Cochrane Library, ClinicalTrials.gov, and Google Scholar. RESULTS: A total of eighteen retrospective studies, encompassing 1,770 patients, were analyzed. Of the 702 cases (38.7%) that underwent conservative treatment, 528 cases (75.2%) achieved a cure, while 174 cases (24.8%) were unsuccessful, with 93 experiencing PA recurrence and 81 developing FIA. In contrast, among the 1,068 cases (61.3%) that received surgical interventions, 784 cases (73.4%) were cured, whereas 284 cases (26.6%) were not, with 151 experiencing PA recurrence and 133 developing FIA. CONCLUSION: The available studies indicate minimal differences in the cure and recurrence rates of PA and FIA between the conservative and surgical treatment groups. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/, PROSPERO (CRD42023472249).",
      "provenance": [
        {
          "field": "n",
          "quote": "eighteen retrospective studies, encompassing 1,770 patients, were analyzed"
        },
        {
          "field": "population",
          "quote": "The optimal treatment approach for perianal abscess (PA) and fistula-in-ano (FIA) in infants remains a subject of debate."
        },
        {
          "field": "intervention",
          "quote": "Of the 702 cases (38.7%) that underwent conservative treatment, 528 cases (75.2%) achieved a cure"
        },
        {
          "field": "comparator",
          "quote": "among the 1,068 cases (61.3%) that received surgical interventions, 784 cases (73.4%) were cured"
        },
        {
          "field": "primaryOutcome",
          "quote": "528 cases (75.2%) achieved a cure, while 174 cases (24.8%) were unsuccessful, with 93 experiencing PA recurrence and 81 developing FIA"
        },
        {
          "field": "result",
          "quote": "The available studies indicate minimal differences in the cure and recurrence rates of PA and FIA between the conservative and surgical treatment groups."
        }
      ]
    },
    {
      "id": "pmid:39833536",
      "pmid": "39833536",
      "doi": "10.1007/s00192-024-06035-4",
      "nctId": null,
      "pmcid": null,
      "title": "Fistulae Secondary to Vaginal Pessary Use for Pelvic Organ Prolapse: A Systematic Review",
      "firstAuthor": "Curtis",
      "multipleAuthors": true,
      "journal": "Int Urogynecol J",
      "year": 2025,
      "design": "systematic-review",
      "n": 76,
      "nField": "reported",
      "population": "women with pelvic organ prolapse who developed fistulas from using a vaginal pessary",
      "intervention": "non-surgical (conservative) management of the fistula",
      "comparator": "surgical repair of the fistula",
      "primaryOutcome": "whether the fistula healed or resolved",
      "result": "conservative management resulted in size reduction or resolution in 69% of fistulae, while surgical repairs were also often successful",
      "resultDirection": "mixed",
      "quality": "low",
      "qualityWhy": "the evidence comes mostly from case series and reports plus two retrospective studies, which carry high risk of bias and cannot reliably compare treatments",
      "directness": "indirect",
      "limitations": "included mostly case series/reports with risk of bias assessed as significant, retrospective design, and this concerns pessary-related urogenital/rectovaginal fistulas rather than anal fistula",
      "followUp": "",
      "plainFinding": "Many pessary fistulas healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/39833536/",
      "sourceText": "INTRODUCTION AND HYPOTHESIS: Urogenital and rectovaginal fistulae are rare complications of pessary use for pelvic organ prolapse (POP). This systematic review investigates the prevalence of these complications in patients using pessary for POP, potential risk factors and approaches to their investigation and management. METHODS: All studies in English reporting urogenital or rectovaginal fistulae secondary to pessaries for POP were eligible for inclusion. AMED, CINAHL, MedLine, Scopus and Web of Science databases were searched from inception to March 2024. Risk of bias was assessed using validated tools: Murad et al.'s tool for case series/reports and ROBINS-I for non-randomised studies. Quantitative synthesis of descriptive statistics and narrative summary were performed. RESULTS: Two retrospective studies and 60 case series/reports were included, describing 76 fistulae (34 urogenital, 42 rectovaginal). The retrospective studies estimated the prevalence of fistulae to be 3%. Of reported fistulae, 45% occurred with Gellhorn, 16% with ring, 11% with shelf and 9% with cube pessaries. Fifty percent were associated with neglected pessary care. Conservative management resulted in size reduction or resolution in 69% of fistulae: this approach should be considered. Vaginal (88%) and abdominal (100%) vesicovaginal fistula repairs were successful. Diverting ostomies were popular for rectovaginal fistulae but often resulted in permanent stoma without reducing mortality, recurrence or repair failure. Colpocleisis represents an effective procedure for managing co-existing POP. CONCLUSIONS: The prevalence of fistulae from pessary use is likely < 1% but may rise to 3% with risk factors present, including Gellhorn pessaries and neglected care. Both conservative and surgical management are viable treatment options.",
      "provenance": [
        {
          "field": "population",
          "quote": "patients using pessary for POP"
        },
        {
          "field": "intervention",
          "quote": "Conservative management resulted in size reduction or resolution in 69% of fistulae: this approach should be considered."
        },
        {
          "field": "comparator",
          "quote": "Vaginal (88%) and abdominal (100%) vesicovaginal fistula repairs were successful."
        },
        {
          "field": "primaryOutcome",
          "quote": "Conservative management resulted in size reduction or resolution in 69% of fistulae"
        },
        {
          "field": "result",
          "quote": "Conservative management resulted in size reduction or resolution in 69% of fistulae: this approach should be considered."
        },
        {
          "field": "n",
          "quote": "76 fistulae (34 urogenital, 42 rectovaginal)"
        }
      ]
    },
    {
      "id": "pmid:39784726",
      "pmid": "39784726",
      "doi": "10.17235/reed.2024.10904/2024",
      "nctId": null,
      "pmcid": null,
      "title": "Continuous endoscopic manual suturing for colorectal anastomotic fistula closure",
      "firstAuthor": "Palma García",
      "multipleAuthors": true,
      "journal": "Rev Esp Enferm Dig",
      "year": 2026,
      "design": "case-series",
      "n": 1,
      "nField": "reported",
      "population": "a man who developed a fistula where his colon was rejoined after rectal cancer surgery",
      "intervention": "endoscopic manual suturing of the fistula opening (after argon treatment)",
      "comparator": "an earlier attempt to close it with vacuum-assisted closure",
      "primaryOutcome": "whether the fistula opening closed completely",
      "result": "the fistula closed at first but then reopened, and surgery was ultimately needed",
      "resultDirection": "no-benefit",
      "quality": "very-low",
      "qualityWhy": "this is a single patient case report, so it cannot show whether this approach generally works.",
      "directness": "indirect",
      "limitations": "single case, not a classic anal fistula but a post-surgical anastomotic fistula, no comparison group, short observation before switching to surgery",
      "followUp": "one month of hospitalization",
      "plainFinding": "Suturing failed, surgery still needed.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/39784726/",
      "sourceText": "A 54-year-old male underwent a low anterior resection in 2015 for rectal adenocarcinoma. He presented to the emergency department with a two-week history of fever, perianal pain, an erythematous, warm, and actively draining mass. Physical examination revealed a perianal abscess in the left posterior gluteal region, with a palpable internal fistulous orifice 3 cm from the anal margin. Abdominal and pelvic CT and MRI demonstrated a discontinuity in the distal sigmoid colon pre-anastomotic, communicating with a perirectal abscess and an extrasphincteric fistulous tract towards the left ischioanal fat. Despite initial antibiotic therapy with amoxicillin/clavulanic and poor clinical response, colonoscopy revealed a 10 mm, erythematous, and friable fistulous orifice at the anastomosis. Histopathology did not reveal any adenomatous or dysplastic tissue. Vacuum-assisted closure was attempted but was unsuccessful due to technical difficulties and the small size of the cavity. Given the characteristics of the fistula, we proceeded with continuous manual suturing after argon application, achieving complete closure of the fistulous opening. However, after two weeks, there was a sluggish evolution. A follow-up colonoscopy showed persistence of the fistulous orifice with suture material, although radiologically there was a clear decrease in the abscess. Finally, after one month of hospitalization with a stable fistula but no definitive resolution, a planned surgical intervention was decided.",
      "provenance": [
        {
          "field": "n",
          "quote": "A 54-year-old male underwent a low anterior resection in 2015 for rectal adenocarcinoma."
        },
        {
          "field": "population",
          "quote": "A 54-year-old male underwent a low anterior resection in 2015 for rectal adenocarcinoma."
        },
        {
          "field": "intervention",
          "quote": "we proceeded with continuous manual suturing after argon application"
        },
        {
          "field": "comparator",
          "quote": "Vacuum-assisted closure was attempted but was unsuccessful due to technical difficulties and the small size of the cavity."
        },
        {
          "field": "primaryOutcome",
          "quote": "achieving complete closure of the fistulous opening"
        },
        {
          "field": "result",
          "quote": "A follow-up colonoscopy showed persistence of the fistulous orifice with suture material, although radiologically there was a clear decrease in the abscess."
        },
        {
          "field": "result",
          "quote": "a planned surgical intervention was decided"
        },
        {
          "field": "followUp",
          "quote": "after one month of hospitalization with a stable fistula but no definitive resolution"
        }
      ]
    },
    {
      "id": "pmid:39709324",
      "pmid": "39709324",
      "doi": "10.1007/s00383-024-05932-5",
      "nctId": null,
      "pmcid": null,
      "title": "Medium- to long-term outcomes of seton placement for fistula-in-ano in children: the experience of 103 patients from a single institution",
      "firstAuthor": "Yang",
      "multipleAuthors": true,
      "journal": "Pediatr Surg Int",
      "year": 2024,
      "design": "case-series",
      "n": 103,
      "nField": "reported",
      "population": "children with anal fistula",
      "intervention": "seton placement (a surgical thread technique for fistula)",
      "comparator": "no comparison group; all patients received seton placement",
      "primaryOutcome": "whether the fistula healed after treatment",
      "result": "97 of 103 patients healed well, 4 healed after further dressing changes and debridement, and 2 needed a second seton procedure for recurrence",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This is a retrospective case series of one surgical technique with no comparison group, so it cannot show whether non-surgical healing is possible.",
      "directness": "indirect",
      "limitations": "Retrospective, single-institution, no control or non-surgical comparison group, and the population is children rather than a general population of fistula patients.",
      "followUp": "23 (6-58) months",
      "plainFinding": "Most fistulas healed after seton surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/39709324/",
      "sourceText": "PURPOSE: The aim of this study was to evaluate the efficacy of seton placement for anal fistula in children. METHODS: The clinical data of children with anal fistula treated by seton placement admitted from January 2017 to September 2022 were retrospectively analyzed. Our primary treatments for perianal abscess (PA) are conservative treatment and drainage. Patients with systemic and inflammatory bowel diseases were excluded. RESULTS: The median follow-up time of these patients was 23 (6-58) months, and the median onset age was 16 (3-156) months. Among the 103 patients, 75 with a single fistula and 20 with a double fistula were treated by primary seton placement. Seven patients with multiple fistulas were treated using staged seton placement, and one case using primary seton placement. A total of 97 patients experienced good healing, four patients experienced poor healing and healed after dressing change and debridement, and two patients with multiple fistulas who experienced recurrence underwent a second seton placement. The average healing time was four (1-10) weeks. CONCLUSION: The medium- to long-term outcome of seton placement indicates that this procedure is safe and effective in the treatment of anal fistula in children.",
      "provenance": [
        {
          "field": "population",
          "quote": "The clinical data of children with anal fistula treated by seton placement admitted from January 2017 to September 2022 were retrospectively analyzed."
        },
        {
          "field": "intervention",
          "quote": "evaluate the efficacy of seton placement for anal fistula in children"
        },
        {
          "field": "comparator",
          "quote": "The clinical data of children with anal fistula treated by seton placement admitted from January 2017 to September 2022 were retrospectively analyzed."
        },
        {
          "field": "primaryOutcome",
          "quote": "The aim of this study was to evaluate the efficacy of seton placement for anal fistula in children."
        },
        {
          "field": "result",
          "quote": "A total of 97 patients experienced good healing, four patients experienced poor healing and healed after dressing change and debridement, and two patients with multiple fistulas who experienced recurrence underwent a second seton placement."
        },
        {
          "field": "n",
          "quote": "Among the 103 patients, 75 with a single fistula and 20 with a double fistula were treated by primary seton placement."
        },
        {
          "field": "followUp",
          "quote": "The median follow-up time of these patients was 23 (6-58) months"
        }
      ]
    },
    {
      "id": "pmid:39693822",
      "pmid": "39693822",
      "doi": "10.1016/j.jpedsurg.2024.162101",
      "nctId": null,
      "pmcid": null,
      "title": "Non-operative Versus Operative Management of Perianal Abscess in Infants: A 10-year Retrospective Study at Two Centres in the United Kingdom",
      "firstAuthor": "Neville",
      "multipleAuthors": true,
      "journal": "J Pediatr Surg",
      "year": 2025,
      "design": "retrospective",
      "n": 116,
      "nField": "reported",
      "population": "infants aged 12 months or younger with a perianal abscess",
      "intervention": "non-operative treatment (antibiotics and/or aspiration under local anaesthetic)",
      "comparator": "operative treatment (incision and drainage under general anaesthesia)",
      "primaryOutcome": "recurrence of the abscess and later development of anal fistula",
      "result": "Abscess recurrence was higher after non-operative treatment, but the rate of later fistula was not significantly different between the two groups",
      "resultDirection": "mixed",
      "quality": "low",
      "qualityWhy": "It is a retrospective chart review from two centres without randomisation, so differences between groups could reflect which infants were chosen for each treatment rather than the treatment itself.",
      "directness": "indirect",
      "limitations": "Retrospective design, no randomisation, short median follow-up of 3 months, and treatment choice was based on surgeon preference rather than a standard protocol.",
      "followUp": "3 (IQR 2-6) months",
      "plainFinding": "No difference in fistula rates",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/39693822/",
      "sourceText": "BACKGROUND: Perianal abscess (PA), with or without fistula-in-ano (FIA) is common in infants. Treatment options include incision and drainage under general anaesthesia or non-operative treatments, such as antibiotics and/or aspiration under local anaesthetic, which avoid the risks of surgery. Current management is based on surgeon preference due to a poor underlying evidence base. In this study we aimed to compare outcomes for non-operative and operative management of infant PA. METHODS: 10-year retrospective review (2012-2022) of infants aged ≤12 months presenting with PA to two paediatric surgery centres in the United Kingdom. Clinical features, management and outcome data were extracted from electronic records. RESULTS: 116 infants were identified; 113/116 (97 %) were male. Median age at presentation was 2 (IQR 1-6) months. Initial management was non-operative in 73/116 (63 %) and operative in 43/80 (37 %). Median follow-up was 3 (IQR 2-6) months. Recurrence occurred in 49/116 (42 %) at a median time of 1 (IQR 0-3) month and was significantly higher in the non-operative compared to the operative group (39/73 [53 %] versus 10/43 [23 %], p = 0.001). Operative management was independently associated with a reduced risk of PA recurrence (OR 0.25 [95 % confidence interval 0.09-0.68], p = 0.007). Further surgery was performed in 26/73 (36 %) in the non-operative group and 7/43 (16 %) in the operative group (p = 0.026). Subsequent FIA rates were not significantly different (23/73 [32 %] versus 8/43 [19 %], p = 0.129). CONCLUSIONS: In this study, PA recurrence and the requirement for further operative intervention were significantly higher when a PA was initially managed non-operatively, although subsequent FIA rates were similar.",
      "provenance": [
        {
          "field": "population",
          "quote": "infants aged ≤12 months presenting with PA to two paediatric surgery centres in the United Kingdom"
        },
        {
          "field": "intervention",
          "quote": "non-operative treatments, such as antibiotics and/or aspiration under local anaesthetic"
        },
        {
          "field": "comparator",
          "quote": "incision and drainage under general anaesthesia"
        },
        {
          "field": "primaryOutcome",
          "quote": "Recurrence occurred in 49/116 (42 %)"
        },
        {
          "field": "n",
          "quote": "116 infants were identified"
        },
        {
          "field": "result",
          "quote": "Recurrence occurred in 49/116 (42 %) at a median time of 1 (IQR 0-3) month and was significantly higher in the non-operative compared to the operative group (39/73 [53 %] versus 10/43 [23 %], p = 0.001)"
        },
        {
          "field": "result",
          "quote": "Subsequent FIA rates were not significantly different (23/73 [32 %] versus 8/43 [19 %], p = 0.129)"
        },
        {
          "field": "followUp",
          "quote": "Median follow-up was 3 (IQR 2-6) months"
        }
      ]
    },
    {
      "id": "pmid:37891236",
      "pmid": "37891236",
      "doi": "10.1038/s41598-023-45751-7",
      "nctId": null,
      "pmcid": "PMC10611711",
      "title": "Natural course of perianal abscess in infants: a real-world study",
      "firstAuthor": "Yin",
      "multipleAuthors": true,
      "journal": "Sci Rep",
      "year": 2023,
      "design": "retrospective",
      "n": 153,
      "nField": "reported",
      "population": "infants with perianal abscess treated without surgery",
      "intervention": "conservative (non-surgical) treatment of perianal abscess",
      "comparator": "surgical treatment",
      "primaryOutcome": "cure without surgery, and development of fistula or recurrent abscess",
      "result": "90.8% were cured without surgery, 7.2% eventually needed surgery, and 2% developed an anal fistula",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This was a retrospective, single-center study where parents chose to avoid surgery, so there is no random comparison and results may not apply to all patients.",
      "directness": "indirect",
      "limitations": "Retrospective design, single center, treatment chosen by parental refusal of surgery rather than randomization, and the study is about perianal abscess rather than established anal fistula.",
      "followUp": "5.3 years (range 3-8.2 years)",
      "plainFinding": "Most infant abscesses healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/37891236/",
      "sourceText": "Natural course of perianal abscess (PA) in infancy remains obscure. This study aimed to investigate the natural course of infants with PA after conservative treatment. A retrospective cohort study was conducted in infants with PA who were treated conservatively (due to the parents' refusal of surgery), for more than 2 months between 2014 and 2020 at a single tertiary center. 153 patients (149 boys and 4 girls) were identified. The median follow-up was 5.3 years (range 3-8.2 years). Initially, 119 patients (77.8%) were completely cured by conservative treatment, and 34 (22.2%) failed. Among the 34 patients, 23 continued conservative treatment (20 cure, 3 fistula formation) and 11 underwent surgery. After conservative treatment, the rate of fistula formation, abscess recurrence, and new-onset abscess were 15.0%, 4.6%, and 6.5%, respectively. Overall, 139 patients (90.8%) were cured conservatively without surgery, and 11 (7.2%) underwent surgical management. In addition, 3 (2.0%) patients developed fistula-in-ano (under observation). PA in infants may be a time-limited and self-limited condition. Conservative management should be the first choice of treatment in most cases. Longer periods of conservative treatment may achieve better clinical outcomes in selected cases. There will be a percentage of patients (about 10%) that would require surgical treatment.",
      "provenance": [
        {
          "field": "population",
          "quote": "infants with PA who were treated conservatively (due to the parents' refusal of surgery), for more than 2 months between 2014 and 2020"
        },
        {
          "field": "intervention",
          "quote": "conservative treatment"
        },
        {
          "field": "comparator",
          "quote": "11 underwent surgery"
        },
        {
          "field": "primaryOutcome",
          "quote": "the rate of fistula formation, abscess recurrence, and new-onset abscess"
        },
        {
          "field": "result",
          "quote": "Overall, 139 patients (90.8%) were cured conservatively without surgery, and 11 (7.2%) underwent surgical management. In addition, 3 (2.0%) patients developed fistula-in-ano (under observation)."
        },
        {
          "field": "n",
          "quote": "153 patients (149 boys and 4 girls) were identified."
        }
      ]
    },
    {
      "id": "pmid:37216694",
      "pmid": "37216694",
      "doi": "10.1177/00031348231175481",
      "nctId": null,
      "pmcid": null,
      "title": "Gracilis Muscle Interposition: A Valuable Tool for the Treatment of Failed Repair of Post-partum Rectovaginal Fistulas-A Single-Center Experience",
      "firstAuthor": "Strassmann",
      "multipleAuthors": true,
      "journal": "Am Surg",
      "year": 2023,
      "design": "case-series",
      "n": 6,
      "nField": "reported",
      "population": "women with rectovaginal fistulas from childbirth injury that had already failed earlier repairs",
      "intervention": "gracilis muscle interposition surgery (a muscle flap placed to close the fistula)",
      "comparator": "no comparison group; outcomes compared with patients' own prior failed procedures",
      "primaryOutcome": "whether the fistula leakage was gone after the temporary stoma was reversed",
      "result": "4 of 6 patients healed after the muscle flap surgery; the other 2 healed after one more small procedure, giving 100% eventual success",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "This is a tiny retrospective series of only 6 patients with no comparison group, so it can't reliably show whether fistulas heal without surgery.",
      "directness": "indirect",
      "limitations": "Very small sample, single center, retrospective, no control group, and all patients underwent surgery (with fecal diversion) rather than being observed for non-surgical healing.",
      "followUp": "",
      "plainFinding": "Muscle flap surgery closed recurrent fistulas.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/37216694/",
      "sourceText": "INTRODUCTION: Rectovaginal fistulas (RVFs) account for approximately 40% of anorectal complications from obstetrical trauma. Treatment can be challenging requiring multiple surgical repairs. Interposition of healthy transposed tissue (lotus or Martius flap or gracilis muscle) has been used for recurrent RVF. We aimed to review our experience with gracilis muscle interposition (GMI) for post-partum RVF. METHODS: A retrospective analysis of patients who underwent GMI for post-partum RVF from February 1995 to December 2019 was undertaken. Patient demographics, number of prior treatments, comorbidities, tobacco use, postoperative complications, additional procedures, and outcome were assessed. Success was defined as absence of leakage from the repair site after stoma reversal. RESULTS: Six of 119 patients who underwent GMI did so for recurrent post-partum RVF. Median age was 34.2 (28-48) years. All patients had at least 1 previously failed procedure [median: 3 (1-7)] including endorectal advancement flap, fistulotomy, vaginoplasty, mesh interposition, and sphincteroplasty. All patients underwent fecal diversion prior to or at initial procedure. Success was achieved in 4/6 (66.7%) patients; 2 underwent further procedures (1 fistulotomy and 1 rectal flap advancement) for a final 100% success rate as all ileostomies were reversed. Morbidity was reported in 3 (50%) patients, including wound dehiscence, delayed rectoperineal fistula, and granuloma formation in one each, all managed without surgery. There was no morbidity related to stoma closure. CONCLUSIONS: Gracilis muscle interposition is a valuable tool for recurrent post-partum RVF. Our ultimate success rate in this very small series was 100% with a relatively low morbidity rate.",
      "provenance": [
        {
          "field": "population",
          "quote": "patients who underwent GMI for post-partum RVF"
        },
        {
          "field": "intervention",
          "quote": "gracilis muscle interposition (GMI) for post-partum RVF"
        },
        {
          "field": "comparator",
          "quote": "All patients had at least 1 previously failed procedure [median: 3 (1-7)] including endorectal advancement flap, fistulotomy, vaginoplasty, mesh interposition, and sphincteroplasty."
        },
        {
          "field": "primaryOutcome",
          "quote": "Success was defined as absence of leakage from the repair site after stoma reversal."
        },
        {
          "field": "result",
          "quote": "Success was achieved in 4/6 (66.7%) patients; 2 underwent further procedures (1 fistulotomy and 1 rectal flap advancement) for a final 100% success rate as all ileostomies were reversed."
        },
        {
          "field": "n",
          "quote": "Six of 119 patients who underwent GMI did so for recurrent post-partum RVF."
        }
      ]
    },
    {
      "id": "pmid:36894443",
      "pmid": "36894443",
      "doi": "10.1016/j.jpedsurg.2023.01.055",
      "nctId": null,
      "pmcid": null,
      "title": "The Optimal Primary Treatment for Pediatric Perianal Abscess and Anal Fistula: A Systemic Review and Meta-Analysis",
      "firstAuthor": "Lin",
      "multipleAuthors": true,
      "journal": "J Pediatr Surg",
      "year": 2023,
      "design": "meta-analysis",
      "n": 2507,
      "nField": "reported",
      "population": "children under 18 with perianal abscess or anal fistula (without Crohn's disease or malignancy)",
      "intervention": "conservative treatment or drainage (non-surgical initial management)",
      "comparator": "surgery as initial treatment",
      "primaryOutcome": "recurrence after initial treatment",
      "result": "surgery was better at preventing recurrence than conservative treatment or drainage alone",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "No randomized trials were found, only retrospective and small case-series data were pooled.",
      "directness": "indirect",
      "limitations": "No randomized controlled trials identified; studies were retrospective cohorts or small case series; subgroup analysis of specific approaches could not be performed due to lack of information.",
      "followUp": "",
      "plainFinding": "Surgery lowers recurrence more than conservative care.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/36894443/",
      "sourceText": "BACKGROUND: Perianal abscesses and anal fistulas are common. The principle of intention-to-treat has not been considered in previous systemic reviews. Thus, the comparison between primary and post-recurrence management was confused, and the recommendation of primary treatment is obscure. The current study aims to identify the optimal initial treatment for pediatric patients. METHODS: Using PRISMA guidelines, studies were identified from MEDLINE, EMBASE, PubMed, Cochrane Library, and Google Scholar without any language or study design restriction. The inclusion criteria include original articles or articles with original data, studies of management for a perianal abscess with or without anal fistula, and patient age of <18 years. Patients with local malignancy, Crohn's disease, or other underlying predisposing conditions were excluded. Studies without analyzing recurrence, case series of <5, and irrelevant articles were excluded in the screening stage. Of the 124 screened articles, 14 articles had no full texts or detailed information. Articles written in a language other than English or Mandarin were translated by Google Translation first and confirmed with native speakers. After the eligibility process, studies that compared identified primary managements were then included in the qualitative synthesis. RESULTS: Thirty-one studies involving 2507 pediatric patients met the inclusion criteria. The study design consisted of two prospective case series of 47 patients and retrospective cohort studies. No randomized control trials were identified. Meta-analyses for recurrence after initial management were performed with a random-effects model. Conservative treatment and drainage revealed no difference (Odds ratio [OR], 1.222; 95% Confidential interval [CI]: 0.615-2.427, p = 0.567). Conservative management had a higher risk of recurrence than surgery without statistical significance (OR 0.278, 95% CI: 0.109-0.707, p = 0.007). Compared with incision/drainage, surgery can prevent recurrence remarkably (OR 4.360, 95% CI: 1.761-10.792, p = 0.001). Subgroup analysis of different approaches within conservative treatment and operation was not performed for lacking information. CONCLUSION: Strong recommendations cannot be made due to the lack of prospective or randomized controlled studies. However, the current study based on real primary management supports initial surgical intervention for pediatric patients with perianal abscesses and anal fistula to prevent recurrence. LEVEL OF EVIDENCE: Type of study: Systemic review; Evidence level: Level II.",
      "provenance": [
        {
          "field": "n",
          "quote": "Thirty-one studies involving 2507 pediatric patients met the inclusion criteria."
        },
        {
          "field": "population",
          "quote": "patient age of <18 years"
        },
        {
          "field": "intervention",
          "quote": "Conservative treatment and drainage revealed no difference"
        },
        {
          "field": "comparator",
          "quote": "Compared with incision/drainage, surgery can prevent recurrence remarkably"
        },
        {
          "field": "primaryOutcome",
          "quote": "Meta-analyses for recurrence after initial management were performed with a random-effects model."
        },
        {
          "field": "result",
          "quote": "Compared with incision/drainage, surgery can prevent recurrence remarkably (OR 4.360, 95% CI: 1.761-10.792, p = 0.001)."
        },
        {
          "field": "limitations",
          "quote": "Strong recommendations cannot be made due to the lack of prospective or randomized controlled studies."
        }
      ]
    },
    {
      "id": "pmid:35647894",
      "pmid": "35647894",
      "doi": "10.1089/sur.2021.351",
      "nctId": null,
      "pmcid": "PMC9208854",
      "title": "Intermediate-Term Evaluation of Initial Non-Surgical Management of Pediatric Perianal Abscess and Fistula-In-Ano",
      "firstAuthor": "Kang",
      "multipleAuthors": true,
      "journal": "Surg Infect (Larchmt)",
      "year": 2022,
      "design": "retrospective",
      "n": 457,
      "nField": "reported",
      "population": "children with a first-time perianal abscess or anal fistula",
      "intervention": "non-surgical management (no surgery)",
      "comparator": "surgical incision and/or drainage",
      "primaryOutcome": "abscess coming back, fistula forming, and how long the wound took to heal",
      "result": "no significant difference between non-surgical and surgical groups in recurrence, fistula formation or healing, but the non-surgical group had fewer hospital admissions and procedures",
      "resultDirection": "no-benefit",
      "quality": "low",
      "qualityWhy": "this was a retrospective chart review without randomization, so differences between groups could be due to selection rather than treatment.",
      "directness": "indirect",
      "limitations": "Retrospective design, pediatric population only, and abscess and fistula patients analyzed together rather than fistula alone.",
      "followUp": "",
      "plainFinding": "No surgery, similar healing outcomes.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/35647894/",
      "sourceText": "Background: Non-surgical intervention has been proposed for the management of perianal abscess (PA) and fistula-in-ano (FIA), with potential benefits in terms of quality of life, wound healing, and functional outcome, although this strategy remains rare and controversial. Here, we aimed to compare the intermediate-term outcomes of non-surgical management with those of surgical incision and/or drainage. Patients and Methods: A study of pediatric patients with first-time PA and/or FIA was conducted retrospectively from January 2010 to December 2020. The patient population was stratified by surgical and non-surgical management. The clinical outcomes, including PA recurrence, FIA formation, and wound healing time, were compared between the surgical and non-surgical management groups. Results: A total of 457 patients managed for first-time PA and/or FIA were eligible for the current study. Of these patients, 169 (50.9%) patients received non-surgical intervention. There were no differences in terms of age, gender distribution, wound healing course, or abscess size between the two groups. Furthermore, no difference was noted between the two groups in terms of PA recurrence and/or FIA development rates and revisits for additional treatment. Conclusions: Although PA/FIA management is still controversial, non-surgical intervention exhibited promising outcomes for most cases of first-time PA/FIA, with fewer hospital admissions and surgical procedures and similar recurrence and fistula formation incidences. Immediate surgical intervention might be avoided because PA/FIA has a chance for spontaneous resolution in children.",
      "provenance": [
        {
          "field": "n",
          "quote": "A total of 457 patients managed for first-time PA and/or FIA were eligible for the current study."
        },
        {
          "field": "population",
          "quote": "A study of pediatric patients with first-time PA and/or FIA was conducted retrospectively"
        },
        {
          "field": "intervention",
          "quote": "169 (50.9%) patients received non-surgical intervention"
        },
        {
          "field": "comparator",
          "quote": "compare the intermediate-term outcomes of non-surgical management with those of surgical incision and/or drainage"
        },
        {
          "field": "primaryOutcome",
          "quote": "The clinical outcomes, including PA recurrence, FIA formation, and wound healing time, were compared between the surgical and non-surgical management groups."
        },
        {
          "field": "result",
          "quote": "no difference was noted between the two groups in terms of PA recurrence and/or FIA development rates and revisits for additional treatment"
        },
        {
          "field": "result",
          "quote": "non-surgical intervention exhibited promising outcomes for most cases of first-time PA/FIA, with fewer hospital admissions and surgical procedures and similar recurrence and fistula formation incidences"
        }
      ]
    },
    {
      "id": "pmid:34515655",
      "pmid": "34515655",
      "doi": "10.5604/01.3001.0015.2335",
      "nctId": null,
      "pmcid": null,
      "title": "Statement of the polish expert group on the current practice and prospects for the treatment of complex perianal fistulas in Crohn&apos;s disease. Update 2021",
      "firstAuthor": "Banasiewicz",
      "multipleAuthors": true,
      "journal": "Pol Przegl Chir",
      "year": 2021,
      "design": "guideline",
      "n": null,
      "nField": "not-reported",
      "population": "people with perianal fistulas caused by Crohn's disease",
      "intervention": "combination of surgical and drug (medication) therapy",
      "comparator": "surgical treatment alone or drug treatment alone",
      "primaryOutcome": "how effective fistula treatment is",
      "result": "combining surgery and medication worked better than either approach by itself",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "This is an expert group statement summarizing opinions and practice recommendations, not a study with original patient data or measured outcomes.",
      "directness": "indirect",
      "limitations": "No study design, patient numbers, or outcome data are given; this is a consensus/expert opinion document specifically about Crohn's-related fistulas, not fistulas in general.",
      "followUp": "",
      "plainFinding": "Surgery plus drugs works best, Crohn's fistulas.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/34515655/",
      "sourceText": "Perianal fistulas in Crohn's disease (CD) are a major problem. In majority of patient, inflammation involves the rectum. Perianal fistulas in CD pose a diagnostic and therapeutic challenge due to severe symptoms and worse prognosis compared to cryptogenic fistulas. The accurate diagnosis is crucial for an effective treatment of CD-related perianal fistulas, and the following should be determined: anatomy of the fistula, possible strictures and inflammation of the alimentary tract, including the rectum and the anal canal. Treatment of fistulas might be challenging and requires cooperation between the colorectal surgeon and the gastroenterologist. The combination of surgical and pharmacological therapy is more effective than surgical or pharmacological therapy alone. In conservative treatment, aminosalicylates or steroids have little significance. In everyday practice, antibacterial chemotherapeutics, antibiotics and thiopurines are applied. The most effective are TNF-neutralizing antibodies, i.e. infliximab (IFX), adalimumab (ADA) and certolizumab (CER). Surgical management can be urgent including drainage. Elective procedures include dissection of the fistula (simple fistula) or more complex interventions such as mucosal flap or ligation of the intersphincteric portion of the fistula. Surgical interventions can be enhanced using the video-assisted anal fistula treatment (VAAFT) or negative-pressure therapy. In extreme cases, creation of a stoma may be necessary. Also, tissue glues or so-called plugs may be applied in managing perianal fistulas. The use of stem cells seems promising, i.e. application of multipotent non-hematopoietic stem cells around the fistula in order to induce immunomodulation and wound healing.",
      "provenance": [
        {
          "field": "population",
          "quote": "Perianal fistulas in Crohn's disease (CD) are a major problem."
        },
        {
          "field": "intervention",
          "quote": "The combination of surgical and pharmacological therapy is more effective than surgical or pharmacological therapy alone."
        },
        {
          "field": "comparator",
          "quote": "is more effective than surgical or pharmacological therapy alone"
        },
        {
          "field": "result",
          "quote": "The combination of surgical and pharmacological therapy is more effective than surgical or pharmacological therapy alone."
        },
        {
          "field": "primaryOutcome",
          "quote": "Treatment of fistulas might be challenging and requires cooperation between the colorectal surgeon and the gastroenterologist."
        }
      ]
    },
    {
      "id": "pmid:34490496",
      "pmid": "34490496",
      "doi": "10.1007/s00247-021-05158-w",
      "nctId": null,
      "pmcid": null,
      "title": "Perianal magnetic resonance imaging findings and their potential impact on outcome in children with perianal fistulizing Crohn disease",
      "firstAuthor": "Khan",
      "multipleAuthors": true,
      "journal": "Pediatr Radiol",
      "year": 2021,
      "design": "retrospective",
      "n": 99,
      "nField": "reported",
      "population": "children with Crohn disease and perianal fistula who had pelvic MRI",
      "intervention": "MRI-identified fistula features (branching, supralevator extension, sphincter damage) and age",
      "comparator": "children without these MRI features",
      "primaryOutcome": "whether the child later needed surgery for the fistula",
      "result": "Fistula branching and older age at MRI were linked to a higher chance of later needing surgery",
      "resultDirection": "unclear",
      "quality": "low",
      "qualityWhy": "This is a retrospective review of one hospital's records, not a trial testing treatments, so it cannot show whether fistulas heal without surgery.",
      "directness": "indirect",
      "limitations": "Retrospective design, single cohort, only MR-identified features and age analyzed, no comparison of treatment types or healing without surgery reported.",
      "followUp": "5.5 years",
      "plainFinding": "Complex fistulas more likely need surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/34490496/",
      "sourceText": "BACKGROUND: Children with perianal fistulizing Crohn disease require intensive medical management but also have a higher risk for subsequent surgical interventions. OBJECTIVE: We performed a retrospective study to identify patient factors and perianal anatomical features by pelvic MR that are associated with surgical interventions in these children. MATERIALS AND METHODS: We included children with Crohn disease and perianal fistula who underwent pelvic MR with available, archived images and collected demographic, clinical and laboratory data. Radiologists reviewed pelvic MR exams and identified Park classification and additional anatomical features of perianal fistulas, including fistula branching, horseshoe ramifications, abscess, inflammatory mass, supralevator extension, anal sphincter damage, proctitis and posterior anal space involvement. We performed univariate and subsequent multivariate analysis to determine features associated with subsequent surgical intervention. RESULTS: Ninety-nine children with Crohn disease underwent pelvic MR. In this cohort, 69 children had no surgical interventions prior to baseline MRI, with subsequent median clinical follow-up of 5.5 years. Univariate analysis demonstrated that branching (P=0.009), supralevator extension (P=0.015) and anal sphincter damage (P=0.031) were significantly associated with subsequent surgical intervention. Age at baseline MRI was also associated with intervention (hazard ratio [HR] every 5 years: 2.13; 95% confidence interval [CI]: 1.18-3.83; P=0.012). A multivariable model identified only fistula branching (HR: 2.31; 95% CI: 1.28-4.15; P=0.005) and age (HR: 5.18; CI: 1.57-17.14; P=0.007) as independent predictors of subsequent surgery. No demographic, clinical or laboratory parameter predicted subsequent surgical intervention. CONCLUSION: Age and anatomical MR features indicating fistula complexity (branching, supralevator extension) and sphincter damage confer a higher risk of subsequent surgical intervention in children with perianal Crohn disease.",
      "provenance": [
        {
          "field": "n",
          "quote": "Ninety-nine children with Crohn disease underwent pelvic MR."
        },
        {
          "field": "population",
          "quote": "children with Crohn disease and perianal fistula who underwent pelvic MR"
        },
        {
          "field": "intervention",
          "quote": "Radiologists reviewed pelvic MR exams and identified Park classification and additional anatomical features of perianal fistulas, including fistula branching, horseshoe ramifications, abscess, inflammatory mass, supralevator extension, anal sphincter damage, proctitis and posterior anal space involvement."
        },
        {
          "field": "comparator",
          "quote": "69 children had no surgical interventions prior to baseline MRI"
        },
        {
          "field": "primaryOutcome",
          "quote": "features associated with subsequent surgical intervention"
        },
        {
          "field": "result",
          "quote": "A multivariable model identified only fistula branching (HR: 2.31; 95% CI: 1.28-4.15; P=0.005) and age (HR: 5.18; CI: 1.57-17.14; P=0.007) as independent predictors of subsequent surgery."
        },
        {
          "field": "followUp",
          "quote": "subsequent median clinical follow-up of 5.5 years"
        }
      ]
    },
    {
      "id": "pmid:33787391",
      "pmid": "33787391",
      "doi": "10.1177/15533506211006080",
      "nctId": null,
      "pmcid": null,
      "title": "Chemical Ablation for Treating Anal Fistulas without Surgical Intervention: Long-Term Results",
      "firstAuthor": "Attaallah",
      "multipleAuthors": true,
      "journal": "Surg Innov",
      "year": 2021,
      "design": "prospective-cohort",
      "n": 186,
      "nField": "reported",
      "population": "Adults with symptomatic anal fistula",
      "intervention": "Chemical ablation of the fistula tract using 5% silver nitrate solution",
      "comparator": "No comparator group; single-arm study",
      "primaryOutcome": "Rate of complete clinical healing of the fistula after long-term follow-up",
      "result": "44% of patients achieved complete clinical healing; healing was more likely with intermittent discharge and fistulas without abscesses or secondary tracts",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This was a single-arm study without a surgical comparison group, so it cannot show whether chemical treatment works better or worse than surgery.",
      "directness": "direct",
      "limitations": "No control or comparator group was used; the abstract does not mention blinding or randomization.",
      "followUp": "50 (7-64) months",
      "plainFinding": "Fistula healed without surgery in some patients.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/33787391/",
      "sourceText": "Purposes. This study aimed to evaluate long-term outcomes after the application of a corrosive chemical agent for ablation of epithelial tissue as a non-surgical treatment of anal fistulas. Methods. Adult patients with symptomatic perianal fistula were prospectively included in the study. The fistula tract was irrigated with a 5% silver nitrate solution. The primary outcome measured in this study was the rate of clinical healing after long-term follow-up. Factors that may affect healing were also analysed. Results. A total of 186 patients with anal fistula were analysed. After irrigation with silver nitrate, 82 (44%) patients had complete clinical healing during a median follow-up time of 50 (7-64) months. Patients with intermittent discharge had a significantly higher rate of complete clinical healing than those with continuous discharge (P < .04). Fistulas without abscesses or secondary tracts had a significantly higher rate of complete clinical healing than the other types (P = .007). Conclusion. Chemical ablation of the epithelium of the anal fistula yields promising long-term outcomes in the management of anal fistulas without surgical intervention.",
      "provenance": [
        {
          "field": "population",
          "quote": "Adult patients with symptomatic perianal fistula"
        },
        {
          "field": "intervention",
          "quote": "The fistula tract was irrigated with a 5% silver nitrate solution."
        },
        {
          "field": "comparator",
          "quote": "A total of 186 patients with anal fistula were analysed."
        },
        {
          "field": "primaryOutcome",
          "quote": "The primary outcome measured in this study was the rate of clinical healing after long-term follow-up."
        },
        {
          "field": "result",
          "quote": "82 (44%) patients had complete clinical healing during a median follow-up time of 50 (7-64) months"
        },
        {
          "field": "result",
          "quote": "Patients with intermittent discharge had a significantly higher rate of complete clinical healing than those with continuous discharge (P < .04)."
        },
        {
          "field": "result",
          "quote": "Fistulas without abscesses or secondary tracts had a significantly higher rate of complete clinical healing than the other types (P = .007)."
        },
        {
          "field": "n",
          "quote": "A total of 186 patients with anal fistula were analysed."
        },
        {
          "field": "followUp",
          "quote": "median follow-up time of 50 (7-64) months"
        }
      ]
    },
    {
      "id": "pmid:33254180",
      "pmid": "33254180",
      "doi": "10.24875/CIRU.20000926",
      "nctId": null,
      "pmcid": null,
      "title": "Urgent care practice in anorectal abscess. Still a pending task",
      "firstAuthor": "Arroyo-Martinez",
      "multipleAuthors": true,
      "journal": "Cir Cir",
      "year": 2020,
      "design": "retrospective",
      "n": 190,
      "nField": "reported",
      "population": "patients treated for anorectal abscess in an emergency department",
      "intervention": "emergency treatment of anorectal abscess (mostly simple drainage, with or without antibiotics)",
      "comparator": "different treatment approaches used in the emergency department (varying use of antibiotics, referral practices)",
      "primaryOutcome": "risk factors for abscess recurrence",
      "result": "having an associated anal fistula was the only factor linked to abscess coming back",
      "resultDirection": "unclear",
      "quality": "low",
      "qualityWhy": "this is a retrospective, single-center study without a control group comparing surgery versus no surgery for fistula healing, so it can't directly answer whether fistulas heal without surgery.",
      "directness": "indirect",
      "limitations": "retrospective design, single center, no direct comparison of surgical versus non-surgical fistula treatment, and the abstract notes 'great clinical variability' in care with no clear impact on outcomes",
      "followUp": "",
      "plainFinding": "Fistula linked to abscess recurrence.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/33254180/",
      "sourceText": "AIM: The aim of the study was to evaluate urgent care practice with regard to anorectal abscesses (AA) in a tertiary-level referral hospital. MATERIALS AND METHODS: this was retrospective and unicentric study. Patients who underwent surgery for AA between 2016 and 2017 were included in the study. Demographic variables were analyzed as well as the treatment performed, the need for hospitalization, use of antibiotics, and referral to the coloproctology outpatient department (COD). The recurrence risk factors were also evaluated. RESULTS: A total of 220 evaluations under anesthesia were performed, corresponding to 190 patients, 129 males (mean age 46 ± 14.9 years). The most frequent treatment in the emergency department (ED) was simple drainage (75.8%). Antibiotic therapy was prescribed in 62.9% of the cases. A total of 41.1% of the patients were referred to a specialized COD. The only risk factor associated with recurrence was the presence of an associated anal fistula. CONCLUSIONS: Anorectal abscesses are very frequent in the ED. There is great clinical variability regarding the taking of cultures, prescription of antibiotics, and referral criteria to a specialized coloproctology outpatient department, without clear impact of any of them on the recurrence of the abscess.",
      "provenance": [
        {
          "field": "n",
          "quote": "corresponding to 190 patients"
        },
        {
          "field": "population",
          "quote": "Patients who underwent surgery for AA between 2016 and 2017 were included in the study"
        },
        {
          "field": "intervention",
          "quote": "The most frequent treatment in the emergency department (ED) was simple drainage (75.8%)"
        },
        {
          "field": "comparator",
          "quote": "There is great clinical variability regarding the taking of cultures, prescription of antibiotics, and referral criteria to a specialized coloproctology outpatient department"
        },
        {
          "field": "primaryOutcome",
          "quote": "The recurrence risk factors were also evaluated"
        },
        {
          "field": "result",
          "quote": "The only risk factor associated with recurrence was the presence of an associated anal fistula"
        }
      ]
    },
    {
      "id": "pmid:33144540",
      "pmid": "33144540",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "Endoscopic treatment of recto-vesical fistula after radical prostatectomy. Our findings in 2 patients",
      "firstAuthor": "Oteo Manjavacas",
      "multipleAuthors": true,
      "journal": "Arch Esp Urol",
      "year": 2020,
      "design": "case-series",
      "n": 2,
      "nField": "reported",
      "population": "patients who developed a recto-vesical fistula after prostate removal surgery",
      "intervention": "minimally invasive endoscopic closure of the fistula plus prolonged bladder catheter use",
      "comparator": "no comparison group",
      "primaryOutcome": "whether the fistula healed, confirmed by imaging",
      "result": "both patients' fistulas healed and stayed closed over follow-up",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "Only two patients were treated with no comparison group, so it can't show how often this works compared to surgery.",
      "directness": "indirect",
      "limitations": "Very small number of patients (2), no control group, and this is a different type of fistula (bladder-to-rectum after prostate surgery) rather than an anal fistula.",
      "followUp": "36 months",
      "plainFinding": "Fistula closed without major surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/33144540/",
      "sourceText": "OBJECTIVE: The recto-vesical fistula (FRV) that follows a radical prostatectomy is an unusual complication and involves a difficult management. A wide variety of surgical aggressive repair techniques are described in literature, including end-colostomy. Furthermore, non-invasive procedures are barely documented. We present 2 cases with an early diagnosis of postoperative FRV resolved with minimally invasive treatment, with the aim to place theset echniques in the therapeutic range. MATERIAL AND METHODS: In both two cases, the diagnosis of VRF was clinical and radiological. First symptoms occurred heterogeneously since one of the fistulas was secondary to rectal perforation and second was evident after removing the bladder catheter in a uneventful postoperative period. Exploration techniques showed low diameter fistulous orifices in both cases. The conservative treatment consisted in the use of transrectal endoscopic approach and minimally invasive techniques for the closure of the fistulous orifice and a prolonged use of the bladder catheter. RESULTS: The two patients were followed up at least 36 months, confirming the resolution of the recto-vesical fistula by cystography and CT. During the follow-up, no patient has required symptomatic treatment or other specific care up to date. CONCLUSIONS: The conservative treatment of the VRF constitutes a non-aggressive alternative to the series of complex surgeries currently used to repair this iatrogenic pathology. The endoscopic closure of iatrogenic fistulas should be claimed as a therapeutic opportunity, although, more experience is needed to state this treatment as a gold standard technique.",
      "provenance": [
        {
          "field": "population",
          "quote": "The recto-vesical fistula (FRV) that follows a radical prostatectomy is an unusual complication"
        },
        {
          "field": "intervention",
          "quote": "The conservative treatment consisted in the use of transrectal endoscopic approach and minimally invasive techniques for the closure of the fistulous orifice and a prolonged use of the bladder catheter."
        },
        {
          "field": "comparator",
          "quote": "We present 2 cases with an early diagnosis of postoperative FRV resolved with minimally invasive treatment"
        },
        {
          "field": "primaryOutcome",
          "quote": "confirming the resolution of the recto-vesical fistula by cystography and CT"
        },
        {
          "field": "result",
          "quote": "The two patients were followed up at least 36 months, confirming the resolution of the recto-vesical fistula by cystography and CT."
        },
        {
          "field": "n",
          "quote": "We present 2 cases with an early diagnosis of postoperative FRV resolved with minimally invasive treatment"
        }
      ]
    },
    {
      "id": "pmid:32785778",
      "pmid": "32785778",
      "doi": "10.1007/s00383-020-04728-7",
      "nctId": null,
      "pmcid": null,
      "title": "Management of perianal abscesses in infants without general anaesthesia: a systematic review of the literature",
      "firstAuthor": "Stokes",
      "multipleAuthors": true,
      "journal": "Pediatr Surg Int",
      "year": 2020,
      "design": "systematic-review",
      "n": 1049,
      "nField": "reported",
      "population": "infants under 24 months old with perianal abscesses",
      "intervention": "treating the abscess without general anaesthesia (antibiotics, baths, needle draining, or local-anaesthetic drainage)",
      "comparator": "historical approach of general anaesthesia for drainage and fistula exploration",
      "primaryOutcome": "how many infants ended up needing general anaesthesia after being treated without it first",
      "result": "75.3% healed completely without further treatment, 23.2% had recurrence or progressed to a fistula, and only 5.6% eventually needed general anaesthesia",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "The evidence comes mostly from retrospective case series with no randomized trials, so it's a weak basis for conclusions.",
      "directness": "indirect",
      "limitations": "No randomized controlled trials; mostly retrospective cohort studies; abstract notes 'lack of well-designed prospective studies'.",
      "followUp": "",
      "plainFinding": "Most infant abscesses healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/32785778/",
      "sourceText": "Perianal abscesses are a common surgical presentation in infants. Historically, general anaesthesia (GA) has been used to facilitate incision and drainage, with or without exploration for a fistula-in-ano (FIA). This review aims to assess outcomes following management of perianal abscesses without GA in infants less than 24 months old. We aim to identify the success of management without GA. Using PRISMA guidelines, studies were identified from MEDLINE, EMBASE and PubMed. Studies including infants less than 24 months with perianal abscesses managed without GA were reviewed. The primary outcome was the number of patients requiring GA following initial management without GA. Secondary outcomes included rates of recurrent perianal abscesses, rates of progression to FIA and time to cure. Nine studies, involving 1049 infants less than 24 months old met inclusion criteria. A total of 1039 (99.0%) were males. Study design consisted of one prospective case series of 18 patients, and eight retrospective cohort studies. There were no randomized control trials. A total of 1037 (98.9%) patients were initially managed without GA. Of these, 59 (5.6%) were documented to subsequently require a general anaesthetic. Treatment modalities included antibiotics, regular baths, needle aspiration, incision and drainage under local anaesthesia, hainosankyuto and fibroblast growth factor. A total of 790 (75.3%) healed primarily without further intervention. A total of 243 (23.2%) were documented to have a recurrence or progression to FIA. All patients who required a subsequent general anaesthetic had progressed to FIA. Despite the lack of well-designed prospective studies, existing evidence supports management of perianal abscesses without initial GA in infants, with more than 75% healing completely. Further research aimed at standardizing care and confirming the safety and efficacy of initial non-operative management are warranted, and may potentially reduce the number of unnecessary initial and subsequent clinical interventions.",
      "provenance": [
        {
          "field": "population",
          "quote": "infants less than 24 months old"
        },
        {
          "field": "intervention",
          "quote": "management of perianal abscesses without GA"
        },
        {
          "field": "comparator",
          "quote": "Historically, general anaesthesia (GA) has been used to facilitate incision and drainage, with or without exploration for a fistula-in-ano (FIA)."
        },
        {
          "field": "primaryOutcome",
          "quote": "The primary outcome was the number of patients requiring GA following initial management without GA."
        },
        {
          "field": "result",
          "quote": "A total of 790 (75.3%) healed primarily without further intervention. A total of 243 (23.2%) were documented to have a recurrence or progression to FIA."
        },
        {
          "field": "result",
          "quote": "Of these, 59 (5.6%) were documented to subsequently require a general anaesthetic."
        },
        {
          "field": "n",
          "quote": "Nine studies, involving 1049 infants less than 24 months old met inclusion criteria."
        },
        {
          "field": "qualityWhy",
          "quote": "Despite the lack of well-designed prospective studies, existing evidence supports management of perianal abscesses without initial GA in infants"
        }
      ]
    },
    {
      "id": "pmid:32408417",
      "pmid": "32408417",
      "doi": "10.3345/cep.2019.00969",
      "nctId": null,
      "pmcid": "PMC7374001",
      "title": "Efficacy of conservative treatment of perianal abscesses in children and predictors for therapeutic failure",
      "firstAuthor": "Boenicke",
      "multipleAuthors": true,
      "journal": "Clin Exp Pediatr",
      "year": 2020,
      "design": "retrospective",
      "n": 113,
      "nField": "reported",
      "population": "children younger than 14 years old with a perianal abscess",
      "intervention": "conservative (non-surgical) treatment of the abscess",
      "comparator": "surgery for the abscess",
      "primaryOutcome": "whether the abscess resolved permanently without needing surgery",
      "result": "only 14 of 113 children were cured by conservative treatment alone, while most eventually needed surgery",
      "resultDirection": "no-benefit",
      "quality": "low",
      "qualityWhy": "it is a retrospective review of children's records without randomization, so differences in who got surgery versus conservative care could bias the findings.",
      "directness": "indirect",
      "limitations": "Retrospective design, no randomization between treatment groups, and the condition studied is perianal abscess rather than an established anal fistula.",
      "followUp": "",
      "plainFinding": "Surgery often needed; conservative care rarely curative.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/32408417/",
      "sourceText": "BACKGROUND: The optimal management of perianal abscess in children is controversial. PURPOSE: To evaluate the efficiency of conservative treatment of perianal abscess in children and identify parameters that predict therapy failure. METHODS: All cases of children younger than 14 years of age with perianal abscesses between 2001-2016 were evaluated. RESULTS: Of the 113 enrolled patients, 64 underwent subsequent surgery for advanced disease (primary surgery group). Conservative treatment was initiated in 49 patients (primary conservative group) but was stopped because of inefficiency in 25 patients, who were referred for surgery after a median 7.03 days (range, 2 to 16 days). The other 24 patients (48%) initially achieved complete remission after conservative treatment, but 10 were readmitted after a median 34 months (range, 3 to 145 months) with recurrent disease. There were no significant differences in permanent success after conservative treatment between infants (10 of 29, 34%) and older children (4 of 20 [20%], P=0.122). Overall, conservative treatment alone was effective in only 14 of 113 patients. Recurrence after surgery occurred in 16 patients (25%) in the primary surgery group and 11 patients (22%) in the primary conservative group (P=0.75). Univariate analysis of predictors for conservative treatment failure revealed inflammatory values (C-reactive protein and white blood count, P=0.017) and abscess size (P=0.001) as significant parameters, whereas multivariate analysis demonstrated that only abscess size (odds ratio, 3.37; P=0.023) was significant. CONCLUSION: Conservative treatment of perianal abscess is permanently efficient in only a minority of children but is not associated with a higher recurrence rate after subsequent surgery. Abscess size is a predictor for therapy failure.",
      "provenance": [
        {
          "field": "population",
          "quote": "All cases of children younger than 14 years of age with perianal abscesses between 2001-2016 were evaluated."
        },
        {
          "field": "n",
          "quote": "Of the 113 enrolled patients, 64 underwent subsequent surgery for advanced disease (primary surgery group)."
        },
        {
          "field": "intervention",
          "quote": "Conservative treatment was initiated in 49 patients (primary conservative group)"
        },
        {
          "field": "comparator",
          "quote": "64 underwent subsequent surgery for advanced disease (primary surgery group)"
        },
        {
          "field": "primaryOutcome",
          "quote": "To evaluate the efficiency of conservative treatment of perianal abscess in children and identify parameters that predict therapy failure."
        },
        {
          "field": "result",
          "quote": "Overall, conservative treatment alone was effective in only 14 of 113 patients."
        }
      ]
    },
    {
      "id": "pmid:32312918",
      "pmid": "32312918",
      "doi": "10.5604/01.3001.0013.8158",
      "nctId": null,
      "pmcid": null,
      "title": "Perianal abscess and fistula-in-ano in children - evaluation of treatment efficacy. Is it possible to avoid recurrence?",
      "firstAuthor": "Bałaż",
      "multipleAuthors": true,
      "journal": "Pol Przegl Chir",
      "year": 2020,
      "design": "retrospective",
      "n": 24,
      "nField": "reported",
      "population": "infants and children with perianal abscess caused by anal fistula",
      "intervention": "surgical fistulotomy (cutting open the fistula tract)",
      "comparator": "non-surgical care such as sitz baths, antibiotics, or incision and drainage without fixing the fistula",
      "primaryOutcome": "recurrence of abscess and fecal incontinence",
      "result": "patients who had the fistula tract surgically opened (fistulotomy) had no recurrence or incontinence, while those treated with drainage alone elsewhere had more severe disease and needed further surgery",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This was a small retrospective study of only 24 children without a randomized comparison group, so it can't reliably prove one treatment is better.",
      "directness": "indirect",
      "limitations": "Retrospective design, small sample size (24 patients), no randomization, and the comparison group's prior treatments were done at other hospitals with unclear standardization.",
      "followUp": "",
      "plainFinding": "Surgery prevented recurrence; drainage alone did not.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/32312918/",
      "sourceText": "INTRODUCTION: Perianal abscess and fistula-in-ano are common findings in infants and children. The perianal abscess is usually a manifestation of a fistula-in-ano. Experience of our center indicates general lack of knowledge of the origin of the abscess and therefore, it is usually treated by incision and drainage, which leads to repeated recurrences. AIM: We aimed to present the optimal management of fistula-in-ano and perianal abscess in order to reduce or even eliminate the risk of recurrence. MATERIAL AND METHODS: The retrospective study included 24 infants with perianal abscess treated at our center between 2013 and 2015. Patients were divided into two groups: group I (50%) was primary treated in our center, while group II had undergone prior surgical interventions in other hospitals. Fistula-in-ano was intraoperatively identified in all patients (100%) and fistulotomy was performed. RESULTS: No fecal incontinence or recurrence of perianal abscess were observed in any of our patients. In group II, the disorder was associated with severe inflammation, some patients underwent an additional surgical intervention, such as incision and drainage of an extensive buttock's abscess; patients required longer antibiotic therapy and prolonged hospitalization. CONCLUSION: Minimally invasive approach (sitz baths, antibiotic therapy, puncture or incision and drainage of the abscess) appears tempting due to its simplicity and lack of need for general anesthesia, but it is associated with a high recurrence rate. Fistulotomy and fistulectomy, which are slightly more invasive procedures, significantly reduce the recurrence rate of fistulain- ano and perianal abscess.",
      "provenance": [
        {
          "field": "population",
          "quote": "The retrospective study included 24 infants with perianal abscess treated at our center between 2013 and 2015."
        },
        {
          "field": "intervention",
          "quote": "Fistula-in-ano was intraoperatively identified in all patients (100%) and fistulotomy was performed."
        },
        {
          "field": "comparator",
          "quote": "Minimally invasive approach (sitz baths, antibiotic therapy, puncture or incision and drainage of the abscess) appears tempting due to its simplicity and lack of need for general anesthesia, but it is associated with a high recurrence rate."
        },
        {
          "field": "primaryOutcome",
          "quote": "No fecal incontinence or recurrence of perianal abscess were observed in any of our patients."
        },
        {
          "field": "result",
          "quote": "Fistulotomy and fistulectomy, which are slightly more invasive procedures, significantly reduce the recurrence rate of fistulain- ano and perianal abscess."
        },
        {
          "field": "n",
          "quote": "The retrospective study included 24 infants with perianal abscess treated at our center between 2013 and 2015."
        }
      ]
    },
    {
      "id": "pmid:32301002",
      "pmid": "32301002",
      "doi": "10.1007/s10151-020-02214-9",
      "nctId": null,
      "pmcid": null,
      "title": "Surgical management of acquired rectourethral fistula: a retrospective analysis of 52 consecutive patients",
      "firstAuthor": "Bislenghi",
      "multipleAuthors": true,
      "journal": "Tech Coloproctol",
      "year": 2020,
      "design": "retrospective",
      "n": 52,
      "nField": "reported",
      "population": "men with rectourethral fistula (an abnormal connection between the rectum and urinary tract), mostly after surgery or radiation",
      "intervention": "various surgical repair procedures tailored to fistula complexity",
      "comparator": "conservative (non-surgical) management",
      "primaryOutcome": "fistula closure and need for permanent urinary/bowel diversion (stoma)",
      "result": "3 of 52 patients healed with conservative management alone; the remaining 49 needed surgery, with cumulative closure reaching 96% after up to three operations",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This is a retrospective case series from one center without a control group comparing surgery to no surgery, so it cannot reliably show whether surgery was truly necessary.",
      "directness": "indirect",
      "limitations": "Retrospective design, no control group, and this is about rectourethral fistula (bladder-to-rectum), not anal fistula, so findings may not directly apply.",
      "followUp": "10.5 (0.5-16.8) years",
      "plainFinding": "Mostly needed surgery to heal.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/32301002/",
      "sourceText": "BACKGROUND: Acquired rectourethral fistula (RUF) is an uncommon complication mostly resulting from surgery or radiation. Standardization of the surgical management is lacking. The aim of this study was to report our experience with surgery for RUF. METHODS: This was a retrospective study of a prospectively maintained clinical database. The surgical strategy was tailored to complexity of RUF, presence of sepsis, history of radiation and residual urinary/fecal functionality. Outcomes measured were RUF closure and permanent fecal/urinary diversion. Impact of radiotherapy was also assessed. RESULTS: Between November 2002 and January 2019, 52 patients were identified (100% males). Median follow-up was 10.5 (0.5-16.8) years. Three patients had RUF closure after conservative management. The remaining 49 patients had a total of 76 procedures. The cumulative closure rate after the first, second and third attempt was 55.1%, 85.7% and 95.9%, respectively. Fistula closure together with preservation of the fecal and urinary function was achieved in 49%, 65.3% and 67.3% after the first, second and third repair, respectively. The overall success rate for transanal, transperineal, restorative transabdominal and non-restorative transabdominal procedures was 35.7%, 64.3%, 57.1% and 94.1%, respectively. A significantly higher rate of urinary/intestinal stomas was observed in the irradiated vs non-irradiated patients (84.2% vs 42.4%; p = 0.004). CONCLUSIONS: Surgery ensured healing in 96% of the patients. Radiotherapy led to higher rate of permanent urinary/fecal diversion. Nearly all irradiated patients who had transabdominal repair end up with a definitive stoma. When transperineal repair with gracilis flap interposition was used, the rate of fistula closure approached 90%. A treatment algorithm is proposed.",
      "provenance": [
        {
          "field": "n",
          "quote": "52 patients were identified (100% males)"
        },
        {
          "field": "population",
          "quote": "Acquired rectourethral fistula (RUF) is an uncommon complication mostly resulting from surgery or radiation."
        },
        {
          "field": "intervention",
          "quote": "The surgical strategy was tailored to complexity of RUF, presence of sepsis, history of radiation and residual urinary/fecal functionality."
        },
        {
          "field": "comparator",
          "quote": "Three patients had RUF closure after conservative management."
        },
        {
          "field": "primaryOutcome",
          "quote": "Outcomes measured were RUF closure and permanent fecal/urinary diversion."
        },
        {
          "field": "result",
          "quote": "Three patients had RUF closure after conservative management. The remaining 49 patients had a total of 76 procedures. The cumulative closure rate after the first, second and third attempt was 55.1%, 85.7% and 95.9%, respectively."
        },
        {
          "field": "followUp",
          "quote": "Median follow-up was 10.5 (0.5-16.8) years."
        }
      ]
    },
    {
      "id": "pmid:32236687",
      "pmid": "32236687",
      "doi": "10.1007/s00120-020-01167-z",
      "nctId": null,
      "pmcid": null,
      "title": "[Fistula surgery]",
      "firstAuthor": "Rosenbaum",
      "multipleAuthors": true,
      "journal": "Urologe A",
      "year": 2020,
      "design": "narrative-review",
      "n": null,
      "nField": "not-reported",
      "population": "People with vesicovaginal or urorectal fistulas (not anal fistula)",
      "intervention": "Temporary catheter drainage as conservative treatment",
      "comparator": "Surgical repair of the fistula",
      "primaryOutcome": "Whether the fistula closes permanently",
      "result": "Surgery closes fistulas at a high rate; conservative catheter drainage can work if caught early, but it covers a different fistula type (vesicovaginal/urorectal), not anal fistula",
      "resultDirection": "mixed",
      "quality": "low",
      "qualityWhy": "This is a general narrative review about vesicovaginal and urorectal fistulas, not anal fistula, so it does not directly answer the question and gives no study numbers.",
      "directness": "indirect",
      "limitations": "No patient numbers, study design, or statistics are given; it discusses a different fistula population than anal fistula.",
      "followUp": "",
      "plainFinding": "Different fistula type, not answered here",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/32236687/",
      "sourceText": "Vesicovaginal fistulas are a rare problem in the western world but are frequent occurrences in developing countries. In Germany the most frequent cause is hysterectomy. Vesicovaginal fistulas can be treated by the transvaginal or transabdominal approach depending on the characteristics of the fistula and the patient. The incidence and complexity of urorectal fistulas increase with the number of cumulative sequences of prostate cancer treatment. Overall there is no clear consensus about the optimal surgical approach route. The surgical treatment of both vesicovaginal and urorectal fistulas is associated with high permanent fistula closure rates; however, for both entities if the fistula is discovered early enough, conservative treatment with a temporary catheter drainage can be tried, depending on the underlying cause. For both conditions fistula repair in irradiated patients shows a much lower success rate. A spontaneous closure of fistulas in radiogenic fistulas is also not to be expected.",
      "provenance": [
        {
          "field": "population",
          "quote": "Vesicovaginal fistulas are a rare problem in the western world but are frequent occurrences in developing countries."
        },
        {
          "field": "population",
          "quote": "The incidence and complexity of urorectal fistulas increase with the number of cumulative sequences of prostate cancer treatment."
        },
        {
          "field": "intervention",
          "quote": "conservative treatment with a temporary catheter drainage can be tried, depending on the underlying cause"
        },
        {
          "field": "comparator",
          "quote": "The surgical treatment of both vesicovaginal and urorectal fistulas is associated with high permanent fistula closure rates"
        },
        {
          "field": "primaryOutcome",
          "quote": "associated with high permanent fistula closure rates"
        },
        {
          "field": "result",
          "quote": "for both entities if the fistula is discovered early enough, conservative treatment with a temporary catheter drainage can be tried, depending on the underlying cause"
        },
        {
          "field": "result",
          "quote": "for both conditions fistula repair in irradiated patients shows a much lower success rate"
        }
      ]
    },
    {
      "id": "pmid:32003166",
      "pmid": "32003166",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "[Conservative management of rectourethral fistula: modern treatment]",
      "firstAuthor": "Popov",
      "multipleAuthors": true,
      "journal": "Urologiia",
      "year": 2019,
      "design": "case-series",
      "n": 5,
      "nField": "reported",
      "population": "patients who developed a recto-urethral fistula after prostate cancer surgery",
      "intervention": "conservative (non-surgical) management: bowel rest, antibiotics, special diet, bladder drainage",
      "comparator": "no comparison group; outcomes tracked within same patients",
      "primaryOutcome": "whether the fistula healed without surgery",
      "result": "4 of 5 patients (80%) had their fistula heal without surgery",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "Very small, uncontrolled case series with only five patients, so the result could easily be due to chance or selection of mild cases.",
      "directness": "indirect",
      "limitations": "Very small sample, no control group, excluded more complicated cases (fecaluria, prior radiotherapy), and this fistula type (recto-urethral, from prostate surgery) differs from an anal fistula.",
      "followUp": "24 month",
      "plainFinding": "Most healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/32003166/",
      "sourceText": "INTRODUCTION: & Objectives. Rectal injury and recto-urethral fistula (RUF) formation are severe complications after surgical treatment of prostate cancer . There are various surgical techniques as well as conservative methods for the treatment of RUF. Nonsurgical approach can be used in nontoxic, minimally symptomatic patients. MATERIALS & METHODS: From 2012 to 2016, 825 patients (mean age 68y) with LPR to be performed were recruited in the study. Postoperatively RUF developed in 7 patients (0.8%) in average in 10 days after surgery. Five cases were uncomplicated presented with pneumaturia, dysuria or urine per rectum. Two patients with fecaluria and previous history of radiotherapy or androgen deprivation were excluded from the study group. Conservative management include: 1)bowel rest 2)broad-spectrum antibiotics after urine culture 3) fully absorbable diet (combination of parenteral and enteral nutrition) 4) bladder drainage (urethral catheter or suprapubic tube). Duration of conservative treatment was 4 weeks. After treatment all patients underwent a voiding cystourethrogram. RESULTS: During the treatment one patient has developed severe UTIs and surgical treatment were perfomed. The remaining 4 patients had spontaneous healing of the fistula and normal cystourethrogram. With the median follow up of 24 month after RUF treatment all 4patients had no fistula signs and they were fully continent. Overall RUF closure using nonsurgical treatment was successful in 4 of 5 cases (80%). CONCLUSIONS: Conservative management of RUF is a highly effective option which can be used to avoid major surgery and temporary colostomy. Nonsurgical treatment is a feasible method in selected patients with RUF.",
      "provenance": [
        {
          "field": "population",
          "quote": "Postoperatively RUF developed in 7 patients (0.8%) in average in 10 days after surgery."
        },
        {
          "field": "population",
          "quote": "Rectal injury and recto-urethral fistula (RUF) formation are severe complications after surgical treatment of prostate cancer"
        },
        {
          "field": "intervention",
          "quote": "Conservative management include: 1)bowel rest 2)broad-spectrum antibiotics after urine culture 3) fully absorbable diet (combination of parenteral and enteral nutrition) 4) bladder drainage (urethral catheter or suprapubic tube)."
        },
        {
          "field": "comparator",
          "quote": "The remaining 4 patients had spontaneous healing of the fistula and normal cystourethrogram."
        },
        {
          "field": "primaryOutcome",
          "quote": "Overall RUF closure using nonsurgical treatment was successful in 4 of 5 cases (80%)."
        },
        {
          "field": "result",
          "quote": "Overall RUF closure using nonsurgical treatment was successful in 4 of 5 cases (80%)."
        },
        {
          "field": "n",
          "quote": "Five cases were uncomplicated presented with pneumaturia, dysuria or urine per rectum."
        },
        {
          "field": "followUp",
          "quote": "With the median follow up of 24 month after RUF treatment all 4patients had no fistula signs and they were fully continent."
        }
      ]
    },
    {
      "id": "pmid:31612187",
      "pmid": "31612187",
      "doi": "10.7417/CT.2019.2155",
      "nctId": null,
      "pmcid": null,
      "title": "The use of Argentum-Quartz® solution in primary or recurrent perianal fistulas: first experience on three cases",
      "firstAuthor": "Palumbo",
      "multipleAuthors": true,
      "journal": "Clin Ter",
      "year": 2019,
      "design": "case-series",
      "n": null,
      "nField": "not-reported",
      "population": "patients with primary or recurrent perianal fistulas, some with Crohn's disease or ulcerative colitis",
      "intervention": "Argentum-Quartz solution applied non-surgically",
      "comparator": "none described",
      "primaryOutcome": "healing of perianal fistula",
      "result": "preliminary data suggest fistula healing is achievable without surgery, sparing the sphincter",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "Only a few cases with no comparison group, so it cannot reliably show whether the treatment works.",
      "directness": "direct",
      "limitations": "Described as preliminary data from a small case series with no control group.",
      "followUp": "",
      "plainFinding": "Non-surgical fistula healing reported.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/31612187/",
      "sourceText": "Primary perianal fistulous pathology represents a painful condition often noticeable in patients affected by Crohn's disease or Ulcerative colitis. It causes difficult defecation and can evolve in perianal abscess that should be urgently ascertained and drained. The present work aims to propose Argentum-Quartz® as valid non-surgical therapeutic treatment in order to reach a more comfortable perianal fistula healing. In fact, our preliminary data allow us to consider Argentum Quartz® ideally employable for treatment of perianal fistulas associated or not with IBDs, representing a reliable sphincter-sparing solution.",
      "provenance": [
        {
          "field": "population",
          "quote": "Primary perianal fistulous pathology represents a painful condition often noticeable in patients affected by Crohn's disease or Ulcerative colitis."
        },
        {
          "field": "intervention",
          "quote": "Argentum-Quartz® as valid non-surgical therapeutic treatment"
        },
        {
          "field": "primaryOutcome",
          "quote": "a more comfortable perianal fistula healing"
        },
        {
          "field": "result",
          "quote": "our preliminary data allow us to consider Argentum Quartz® ideally employable for treatment of perianal fistulas associated or not with IBDs, representing a reliable sphincter-sparing solution."
        },
        {
          "field": "comparator",
          "quote": "non-surgical therapeutic treatment"
        }
      ]
    },
    {
      "id": "pmid:31535505",
      "pmid": "31535505",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "Outcome Of Use Of 1% Silver Nitrate In Patients With Low Lying Perianal Fistula",
      "firstAuthor": "Iqbal",
      "multipleAuthors": true,
      "journal": "J Ayub Med Coll Abbottabad",
      "year": 2019,
      "design": "case-series",
      "n": 76,
      "nField": "reported",
      "population": "patients with low lying perianal (anal) fistula",
      "intervention": "irrigation of the fistula tract with 1% silver nitrate solution",
      "comparator": "none (no comparison group, single-arm study)",
      "primaryOutcome": "complete clinical healing, defined as no symptoms for 10 weeks in a row",
      "result": "58 out of 76 patients (76.3%) achieved complete healing without surgery",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This was a small, single-center study with no control group, so it can't prove silver nitrate itself caused the healing.",
      "directness": "direct",
      "limitations": "No comparator/control group; single-arm design; 3 of 79 patients lost to follow-up; short follow-up period of 10 weeks.",
      "followUp": "10 weeks",
      "plainFinding": "Most fistulas healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/31535505/",
      "sourceText": "BACKGROUND: Anorectal fistula is a common illness which is seen among the middle-aged male patients. Various surgical procedures have been proposed and are associated with the recurrence of the fistula, repeated surgery and in some cases incontinence which may reach up to 43% in complicated fistulas. The purpose of this study was to assess and formulate a non-surgical procedure for fistula in ano through irrigation of the fistula tract with 1% of silver nitrate solution in healing the low perianal fistula. METHODS: Seventy-nine patients presenting to the outpatient department of Ward 3, Surgical unit 1 in Jinnah Postgraduate Medical Centre during a period of 8 months from April to November 2017 with complain of perianal pain and pussy discharge were included in the study. Three patients of the total 79 patients lost to follow up. Outcome measure were cessation of the symptoms for consecutive 10 weeks. RESULTS: Seventy-six patients were assessed and underwent irrigation using this 1% of silver nitrate solution. Out of 76 patients, 58 (76.3%) patients showed complete clinical healing while 18 (23.68%) of patients showed failure to clinical healing. Patients with continuous discharge had a significantly higher rate of complete clinical healing than those with intermittent discharge. CONCLUSIONS: From this study it can be concluded that cauterizing and corrosive properties of silver nitrate are effective in treating the patients with low lying perianal fistula. We suggest that this method should be used as a first line treatment option for all the patients presenting with low lying anal fistula since it is simple, can be easily performed on an OPD basis is minimally invasive and avoids any complication.",
      "provenance": [
        {
          "field": "population",
          "quote": "patients with low lying perianal fistula"
        },
        {
          "field": "intervention",
          "quote": "irrigation of the fistula tract with 1% of silver nitrate solution"
        },
        {
          "field": "comparator",
          "quote": "non-surgical procedure for fistula in ano"
        },
        {
          "field": "primaryOutcome",
          "quote": "Outcome measure were cessation of the symptoms for consecutive 10 weeks."
        },
        {
          "field": "result",
          "quote": "Out of 76 patients, 58 (76.3%) patients showed complete clinical healing while 18 (23.68%) of patients showed failure to clinical healing."
        },
        {
          "field": "n",
          "quote": "Seventy-six patients were assessed and underwent irrigation using this 1% of silver nitrate solution."
        }
      ]
    },
    {
      "id": "pmid:31469939",
      "pmid": "31469939",
      "doi": "10.1111/ped.13996",
      "nctId": null,
      "pmcid": null,
      "title": "Perianal abscess in infants: Amenable to conservative treatment in selected cases",
      "firstAuthor": "Samuk",
      "multipleAuthors": true,
      "journal": "Pediatr Int",
      "year": 2019,
      "design": "retrospective",
      "n": 19,
      "nField": "reported",
      "population": "infants under 24 months with perianal abscess",
      "intervention": "conservative treatment (antibiotics with drainage only if needed)",
      "comparator": "surgical drainage/fistulotomy",
      "primaryOutcome": "whether surgery was ultimately needed",
      "result": "surgical intervention was prevented in 13/17 patients (76.4%) available for follow up",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This was a small, retrospective study of hand-picked ('selected') cases with two patients lost to follow-up, so it can't reliably prove conservative care works for everyone.",
      "directness": "indirect",
      "limitations": "Retrospective design, small sample, only 'selected cases' included, two patients lost to follow up, and the study is about perianal abscess rather than fistula specifically.",
      "followUp": "mean, 22.4 months",
      "plainFinding": "Most infants avoided surgery; one fistula healed alone.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/31469939/",
      "sourceText": "BACKGROUND: Perianal abscess is a common surgical condition in daily pediatric practice. Management is a subject of controversy and a variety of approaches are practiced. While the most frequent approach is drainage with/without fistulotomy, the superiority of this approach and the place of conservative approach has not been established. The aim of this study was to evaluate the outcomes of conservative approach in selected cases of perianal abscesses in infants. METHODS: Data of 19 patients aged <24 months treated conservatively for perianal abscess at a tertiary hospital in 2014-2018 were retrospectively reviewed. RESULTS: Criteria for a conservative approach were: spontaneous drainage into the anal canal (n = 8) or perianal skin (n = 4), and phlegmonous infiltrate with fluid collection detected on ultrasound (n = 7). Mean age at symptom onset was 8.4 months. Twelve patients were managed for the first time. Previous care in seven patients included 1-4 drainage procedures (n = 4), spontaneous drainage (n = 1) and antibiotics (n = 2). Five patients were on oral antibiotics at presentation. After diagnosis, 18 patients received i.v. antibiotics and one, oral antibiotics. Three patients (15.7%) ultimately required surgical drainage; two were lost to follow up. During follow up (mean, 22.4 months) four patients (28.5%) had a single recurrent episode; abscess in three (managed conservatively in two and surgically in one) and fistula-in-ano in one patient that healed spontaneously. Thus, surgical intervention was prevented in 13/17 patients (76.4%) available for follow up. CONCLUSIONS: Perianal abscess in infants is amenable to conservative management in selected cases. Avoiding surgical intervention is advantageous, especially given the high recurrence rate.",
      "provenance": [
        {
          "field": "n",
          "quote": "Data of 19 patients aged <24 months treated conservatively for perianal abscess at a tertiary hospital in 2014-2018 were retrospectively reviewed."
        },
        {
          "field": "population",
          "quote": "Data of 19 patients aged <24 months treated conservatively for perianal abscess"
        },
        {
          "field": "intervention",
          "quote": "evaluate the outcomes of conservative approach in selected cases of perianal abscesses in infants"
        },
        {
          "field": "comparator",
          "quote": "the most frequent approach is drainage with/without fistulotomy"
        },
        {
          "field": "primaryOutcome",
          "quote": "Three patients (15.7%) ultimately required surgical drainage"
        },
        {
          "field": "result",
          "quote": "surgical intervention was prevented in 13/17 patients (76.4%) available for follow up"
        }
      ]
    },
    {
      "id": "pmid:31320233",
      "pmid": "31320233",
      "doi": "10.1016/j.asjsur.2019.06.009",
      "nctId": null,
      "pmcid": null,
      "title": "Non cross-linked equine collagen (Salvecoll-E gel) for treatment of complex ano-rectal fistula",
      "firstAuthor": "Maternini",
      "multipleAuthors": true,
      "journal": "Asian J Surg",
      "year": 2020,
      "design": "prospective-cohort",
      "n": 70,
      "nField": "reported",
      "population": "adults with complex anal fistula",
      "intervention": "collagen gel (Salvecoll-E) injected into the fistula tract after seton removal and minor surgical preparation",
      "comparator": "none (single-arm study, no comparison group)",
      "primaryOutcome": "fistula healing at 12 months",
      "result": "78.5% of patients had a healed fistula, 21.5% had recurrence by 12 months",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This was a small, single-arm study without a comparison group, so it can't show the gel works better than surgery or no treatment.",
      "directness": "indirect",
      "limitations": "No control group, open-label single-arm design, and treatment combined gel injection with prior surgical steps (seton placement, debridement, mucosal suture).",
      "followUp": "12 months",
      "plainFinding": "Most fistulas healed with gel treatment.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/31320233/",
      "sourceText": "BACKGROUND: Fistula-in-ano is one of the most commonly presenting anorectal diseases. Sphincter sparing treatment options should be considered in patients with complex fistulas. Salvecoll-E gel is a native collagen deantigenated and purified, non-cross-linked equine dermal extract, with an amino acid composition identical to human collagen. METHODS: The multicentric trial study was a prospective, single-arm observational clinical study with the objective to assess the efficacy of Salvecoll-E gel for anal fistula repair in 70 patients. All patients had undergone preliminary surgical treatment consisting of positioning of a draining loosing seton that was maintained for a period of 4-6 weeks. After seton removal, a gentle debridement and washing of the fistula track was performed. The scar tissue was removed from the internal orifice. Internal opening was covered by a side-to side mucosal suture. Salvecoll-E was injected through the external opening into the fistula track, the external opening it has been opened. RESULTS: Twelve months after surgery, 55 patients demonstrated a clinically healed fistula (78,5%), 15 patients have a recurrence (21,5%). Most of the recurrences were observed in the first 6 months of treatment (13/15, 86.6%). We don't observe any worsening in CCF score. The results obtained at 1 year certainly seem satisfactory and in line with the best results published in literature using mini-invasive techniques. CONCLUSION: Salvecoll-E gel is a promising non-invasive technique for conservative treatment of anal fistulas, it's well tolerated by the patients and, in case of recurrence, reinjection or all other known techniques are feasible.",
      "provenance": [
        {
          "field": "n",
          "quote": "the efficacy of Salvecoll-E gel for anal fistula repair in 70 patients"
        },
        {
          "field": "population",
          "quote": "Fistula-in-ano is one of the most commonly presenting anorectal diseases. Sphincter sparing treatment options should be considered in patients with complex fistulas."
        },
        {
          "field": "intervention",
          "quote": "Salvecoll-E was injected through the external opening into the fistula track, the external opening it has been opened."
        },
        {
          "field": "comparator",
          "quote": "The multicentric trial study was a prospective, single-arm observational clinical study"
        },
        {
          "field": "primaryOutcome",
          "quote": "Twelve months after surgery, 55 patients demonstrated a clinically healed fistula (78,5%), 15 patients have a recurrence (21,5%)."
        },
        {
          "field": "result",
          "quote": "55 patients demonstrated a clinically healed fistula (78,5%), 15 patients have a recurrence (21,5%)."
        }
      ]
    },
    {
      "id": "pmid:30919811",
      "pmid": "30919811",
      "doi": "10.5604/01.3001.0013.0593",
      "nctId": null,
      "pmcid": null,
      "title": "Statement of the expert group on the current practice and prospects for the treatment of complex perirectal fistulas in the course of Crohn's disease",
      "firstAuthor": "Banasiewicz",
      "multipleAuthors": true,
      "journal": "Pol Przegl Chir",
      "year": 2019,
      "design": "narrative-review",
      "n": null,
      "nField": "not-reported",
      "population": "people with perirectal fistulas caused by Crohn's disease",
      "intervention": "combined surgical and drug treatment (including anti-TNF drugs like infliximab, adalimumab, certolizumab)",
      "comparator": "surgery alone or drug treatment alone",
      "primaryOutcome": "how effectively the fistulas were treated",
      "result": "combined surgical and drug treatment worked better than either approach alone",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "this is an expert group's opinion statement summarizing practice, not a controlled study with original data or a systematic review of evidence.",
      "directness": "direct",
      "limitations": "No original patient data, no study methodology, numbers, or comparative statistics are given; it is a narrative expert opinion piece.",
      "followUp": "",
      "plainFinding": "Combined surgery plus drugs works better alone.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/30919811/",
      "sourceText": "Perirectal fistulas in the course of Crohn's disease (CD) constitute an important problem in this group of patients. They are observed in a vast majority of patients with involvement through colorectal inflammation. Perirectal fistulas in CD present a great diagnostic and therapeutic challenge due to the intensified clinical symptoms and worse prognosis than in the case of crypt originating fistulas. The condition for implementation of effective treatment of perirectal fistulas in the course of CD is the correct diagnosis, defining the anatomy of fistulas, presence of potential stenoses and inflammation in the gastrointestinal tract. Treatment of these fistulas is difficult and requires close cooperation between the colorectal surgeon and the gastroenterologist. The combination of surgical and pharmacological treatment has higher efficacy compared to surgical treatment or pharmacotherapy alone. In conservative treatment, aminosalicylates and steroids are of minor importance, while chemotherapeutics, antibiotics, and thiopurines find application in daily clinical practice. TNF-α neutralizing antibodies such as infliximab (IFX), adalimumab (ADA) or certolizumab (CER) prove to be the most effective. Surgical treatment may be provided as ad hoc; in this case, drainage procedures are recommended, usually with leaving a loose seton. Planned procedures consist in the excision of fistulas (simple fistulas) or performing more complex procedures, such as advancement flaps or ligation of the intersphincteric fistula tract Surgical measures can be complemented by the use of video technology (video-assisted anal fistula treatment VAAFT) or vacuum therapy. In extreme cases, it may be necessary to create the stoma. Treatment of perirectal fistulas includes adhesives or so-called plugs. High hopes may be associated with the introduction of stem cells into clinical practice, which is the administration of non-hematopoietic multipotent cells to the fistulas to induce the phenomenon of immunomodulation and tissue healing.",
      "provenance": [
        {
          "field": "population",
          "quote": "Perirectal fistulas in the course of Crohn's disease (CD) constitute an important problem in this group of patients."
        },
        {
          "field": "intervention",
          "quote": "The combination of surgical and pharmacological treatment has higher efficacy compared to surgical treatment or pharmacotherapy alone."
        },
        {
          "field": "comparator",
          "quote": "surgical treatment or pharmacotherapy alone"
        },
        {
          "field": "primaryOutcome",
          "quote": "higher efficacy"
        },
        {
          "field": "result",
          "quote": "The combination of surgical and pharmacological treatment has higher efficacy compared to surgical treatment or pharmacotherapy alone."
        }
      ]
    },
    {
      "id": "pmid:30187327",
      "pmid": "30187327",
      "doi": "10.1007/s11605-018-3932-5",
      "nctId": null,
      "pmcid": null,
      "title": "Can Perianal Fistula Be Treated Non-surgically with Platelet-Rich Fibrin Sealant?",
      "firstAuthor": "Pérez Lara",
      "multipleAuthors": true,
      "journal": "J Gastrointest Surg",
      "year": 2019,
      "design": "retrospective",
      "n": null,
      "nField": "not-reported",
      "population": "people with anal (perianal) fistula",
      "intervention": "platelet-rich fibrin plug inserted in outpatient clinic without surgery, anaesthesia, curettage or closing the internal opening",
      "comparator": "platelet-rich fibrin plug inserted surgically under anaesthesia, with two different curettage/closure techniques",
      "primaryOutcome": "whether the fistula healed (outcome success) and complication/continence rates",
      "result": "the outpatient non-surgical approach gave results similar to standard surgical plug insertion with traditional curettage, while a different surgical technique using graduated curettes did significantly better than both",
      "resultDirection": "mixed",
      "quality": "low",
      "qualityWhy": "this is a non-randomised comparison of three groups without reported patient numbers, so it is easy for differences between groups to bias the results.",
      "directness": "direct",
      "limitations": "no randomisation described, sample size not reported, and differences in outcomes between techniques reduce certainty about the non-surgical method's true effect.",
      "followUp": "",
      "plainFinding": "Non-surgical plug worked about as well.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/30187327/",
      "sourceText": "INTRODUCTION: In the last 20 years, various procedures have been suggested for the treatment of anal fistula whilst minimising anal sphincter injury and preserving optimal function. Since 2011, patients at our hospital have been treated for anal fistula by means of platelet-rich fibrin plugs. To do so, three different application techniques have been used, the most recent of which is a non-surgical approach. In this paper, we compare and contrast the results obtained by each of these three techniques. MATERIAL AND METHOD: This study compares three procedures in which the anal fistula was sealed using platelet-rich fibrin: for the patients in group A, the plug was surgically inserted, under anaesthesia, and traditional methods were used to curette the fistula tract and close the internal orifice; for those in group B, the plug was surgically inserted, under anaesthesia, after curettage of the fistula tract using a graduated set of cylindrical curettes, and the internal orifice was closed as before; and for those in group C, the plug was inserted during outpatient consultation, without anaesthesia, without curettage and without closure of the internal orifice. RESULTS: The patients in the three groups were homogeneous in terms of sex, age, ASA classification, location of the fistula and previous insertion of the seton. There were no significant differences in morbidity or postoperative continence. However, there was a statistically significant difference in the outcomes achieved, in favour of group B, while groups A and C obtained similar results. CONCLUSIONS: Outpatient treatment of perianal fistula is totally innocuous. It is a very low cost procedure and the results obtained are highly acceptable (similar to those of the surgical insertion of a plug, with traditional curettage). Therefore, we believe this approach should be considered a valid initial treatment for perianal fistula, reserving surgical treatment (curettage and sealing using a cylindrical-curette kit) for cases in which this initial method is unsuccessful. This would avoid many complications and achieve considerable financial savings for the health system.",
      "provenance": [
        {
          "field": "population",
          "quote": "anal fistula"
        },
        {
          "field": "intervention",
          "quote": "for those in group C, the plug was inserted during outpatient consultation, without anaesthesia, without curettage and without closure of the internal orifice"
        },
        {
          "field": "comparator",
          "quote": "for the patients in group A, the plug was surgically inserted, under anaesthesia, and traditional methods were used to curette the fistula tract and close the internal orifice; for those in group B, the plug was surgically inserted, under anaesthesia, after curettage of the fistula tract using a graduated set of cylindrical curettes, and the internal orifice was closed as before"
        },
        {
          "field": "primaryOutcome",
          "quote": "There were no significant differences in morbidity or postoperative continence. However, there was a statistically significant difference in the outcomes achieved"
        },
        {
          "field": "result",
          "quote": "there was a statistically significant difference in the outcomes achieved, in favour of group B, while groups A and C obtained similar results"
        }
      ]
    },
    {
      "id": "pmid:30099529",
      "pmid": "30099529",
      "doi": "10.1093/ibd/izy247",
      "nctId": null,
      "pmcid": null,
      "title": "Clinical Practice Guideline for the Medical Management of Perianal Fistulizing Crohn's Disease: The Toronto Consensus",
      "firstAuthor": "Steinhart",
      "multipleAuthors": true,
      "journal": "Inflamm Bowel Dis",
      "year": 2019,
      "design": "guideline",
      "n": null,
      "nField": "not-reported",
      "population": "people with anal fistulas caused by Crohn's disease",
      "intervention": "medical treatments such as antibiotics, anti-TNF drugs, and immune-suppressing drugs",
      "comparator": "surgical treatment of the fistula",
      "primaryOutcome": "whether the fistula heals or goes into remission",
      "result": "Medical drugs can bring on remission and keep it, but surgery may still be needed if drugs don't work well enough",
      "resultDirection": "mixed",
      "quality": "very-low",
      "qualityWhy": "The guideline itself says the evidence behind these recommendations is generally very low quality with few good trials.",
      "directness": "indirect",
      "limitations": "Evidence quality was rated very low overall, with a scarcity of good randomized controlled trials, so most recommendations are only conditional suggestions.",
      "followUp": "",
      "plainFinding": "Drugs can help; surgery sometimes still needed.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/30099529/",
      "sourceText": "BACKGROUND: Fistulas occur in about 25% of patients with Crohn's disease (CD) and can be difficult to treat. The aim of this consensus was to provide guidance for the management of patients with perianal fistulizing CD. METHODS: A systematic literature search identified studies on the management of fistulizing CD. The quality of evidence and strength of recommendations were rated according to the Grading of Recommendation Assessment, Development and Evaluation (GRADE) approach. Statements were developed through an iterative online platform using a modified Delphi process, then finalized, and voted on by a group of specialists. RESULTS: The quality of evidence for treatment of fistulizing CD was generally of very low quality, and because of the scarcity of good randomized controlled trials (RCTs), these consensus statements generally provide conditional suggestions (5 of 7 statements). Imaging and surgical consultations were recommended in the initial assessment of patients with active fistulizing CD, particularly those with complicated disease. Antibiotic therapy is useful for initial symptom control. Antitumor necrosis factor (anti-TNF) therapy was recommended to induce symptomatic response, and continued use was suggested to achieve and maintain complete remission. The use of concomitant immunosuppressant therapies may be useful to optimize pharmacokinetic parameters when initiating anti-TNF therapy. When there has been an inadequate symptomatic response to medical management strategies, surgical therapy may provide effective fistula healing for some patients. CONCLUSIONS: Optimal management of perianal fistulizing CD requires a collaborative effort between gastroenterologists and surgeons and may include the evidence-based use of existing therapies, as well as surgical assessments and interventions when needed. 10.1093/ibd/izy247_video1izy247.video15978518763001.",
      "provenance": [
        {
          "field": "population",
          "quote": "patients with perianal fistulizing CD"
        },
        {
          "field": "intervention",
          "quote": "Antitumor necrosis factor (anti-TNF) therapy was recommended to induce symptomatic response"
        },
        {
          "field": "comparator",
          "quote": "surgical therapy may provide effective fistula healing for some patients"
        },
        {
          "field": "primaryOutcome",
          "quote": "continued use was suggested to achieve and maintain complete remission"
        },
        {
          "field": "result",
          "quote": "When there has been an inadequate symptomatic response to medical management strategies, surgical therapy may provide effective fistula healing for some patients."
        },
        {
          "field": "qualityWhy",
          "quote": "The quality of evidence for treatment of fistulizing CD was generally of very low quality"
        },
        {
          "field": "limitations",
          "quote": "because of the scarcity of good randomized controlled trials (RCTs), these consensus statements generally provide conditional suggestions (5 of 7 statements)"
        }
      ]
    },
    {
      "id": "pmid:28945635",
      "pmid": "28945635",
      "doi": "10.1097/MIB.0000000000001254",
      "nctId": null,
      "pmcid": null,
      "title": "Comparison of Stromal Vascular Fraction with or Without a Novel Bioscaffold to Fibrin Glue in a Porcine Model of Mechanically Induced Anorectal Fistula",
      "firstAuthor": "Dryden",
      "multipleAuthors": true,
      "journal": "Inflamm Bowel Dis",
      "year": 2017,
      "design": "animal",
      "n": 17,
      "nField": "reported",
      "population": "Pigs with surgically created anal (anorectal) fistulas",
      "intervention": "Stromal vascular fraction (SVF) cells injected alone or delivered via a bioabsorbable scaffold",
      "comparator": "Fibrin glue injection into the fistula",
      "primaryOutcome": "Whether the fistula tract healed (visual and histologic healing)",
      "result": "All 6 fistulas treated with SVF plus scaffold healed, compared with 4 of 6 treated with SVF alone and none of 5 treated with fibrin glue",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "This is a small animal (pig) experiment, not a human study, so it cannot show how human fistulas heal with or without surgery.",
      "directness": "indirect",
      "limitations": "Small number of animals per group, mechanically created (not Crohn's-related) fistulas in pigs, and no human data.",
      "followUp": "4 weeks",
      "plainFinding": "Cell therapy with scaffold healed fistulas better in pigs",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/28945635/",
      "sourceText": "BACKGROUND: Anorectal fistulas (ARFs) are a common, devastating, event in the life of a patient with Crohn's disease. ARFs occur in up to 50% of patients with Crohn's disease. Treatment begins with surgical drainage of the initial abscess, followed by antibiotic therapy, then anti-inflammatory medications. If medical therapy fails to close the fistula tract, surgical intervention is often pursued. Surgery incurs risk of incontinence because of sphincter injury. Increasingly, the role of cell-based therapy is being investigated in ARFs. We evaluated the role a bioabsorbable scaffold plays in delivering cell-based therapy using a porcine model of AFR. METHODS: ARFs were mechanically created and matured by setons. After 28 days, setons were removed; periaortic fat was harvested and processed for stromal vascular fraction (SVF). The cells were labeled with a membrane stain for later identification, then injected into the fistula or implanted through scaffold. Fistulas not treated with cells were injected with fibrin glue. Animals were monitored visually for healing at weeks 2 and 4, then euthanized to evaluate fistulas for histologic healing. RESULTS: All fistulas (6/6) treated with SVF + scaffolds healed by week 2, compared with only 4/6 with just SVF and 0/5 treated with fibrin glue. Scaffolds retained SVF within the fistula tract more readily than injection method and SVF+scaffold treatment accelerated the healing process. Robust neovascularization was also seen in fistulas treated with SVF+scaffold. No adverse events occurred. CONCLUSIONS: Scaffold technology may improve cell-based therapy healing rates for Crohn's ARFs. This advance should be investigated by human trials.",
      "provenance": [
        {
          "field": "population",
          "quote": "ARFs were mechanically created and matured by setons."
        },
        {
          "field": "intervention",
          "quote": "The cells were labeled with a membrane stain for later identification, then injected into the fistula or implanted through scaffold."
        },
        {
          "field": "comparator",
          "quote": "Fistulas not treated with cells were injected with fibrin glue."
        },
        {
          "field": "primaryOutcome",
          "quote": "Animals were monitored visually for healing at weeks 2 and 4, then euthanized to evaluate fistulas for histologic healing."
        },
        {
          "field": "result",
          "quote": "All fistulas (6/6) treated with SVF + scaffolds healed by week 2, compared with only 4/6 with just SVF and 0/5 treated with fibrin glue."
        },
        {
          "field": "n",
          "quote": "6/6) treated with SVF + scaffolds healed by week 2, compared with only 4/6 with just SVF and 0/5 treated with fibrin glue"
        },
        {
          "field": "followUp",
          "quote": "monitored visually for healing at weeks 2 and 4"
        }
      ]
    },
    {
      "id": "pmid:28916253",
      "pmid": "28916253",
      "doi": "10.1016/j.urology.2017.08.049",
      "nctId": null,
      "pmcid": null,
      "title": "The Place of Transanal Endoscopic Surgery in the Treatment of Rectourethral Fistula",
      "firstAuthor": "Serra-Aracil",
      "multipleAuthors": true,
      "journal": "Urology",
      "year": 2018,
      "design": "prospective-cohort",
      "n": 10,
      "nField": "reported",
      "population": "men with rectourethral fistula after prostate cancer surgery",
      "intervention": "conservative treatment (urinary/fecal diversion) or transanal endoscopic surgery to repair the fistula",
      "comparator": "surgical repair vs conservative management, compared across patients",
      "primaryOutcome": "whether the fistula healed",
      "result": "only 2 of 10 fistulas healed without surgery; of those who had transanal surgical repair, only 25% succeeded and most recurred, requiring further surgery",
      "resultDirection": "mixed",
      "quality": "very-low",
      "qualityWhy": "This was a very small study of only 10 patients, not randomized, and focused on a different and more complex type of fistula.",
      "directness": "indirect",
      "limitations": "Very small sample size, observational design without a control group, and the fistula type (rectourethral, after prostate cancer treatment) differs from typical anal fistula.",
      "followUp": "4-6 months",
      "plainFinding": "Few healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/28916253/",
      "sourceText": "OBJECTIVE: To assess the role of transanal endoscopic operation (TEO) or transanal endoscopic microsurgery (TEM) in rectourethral fistulas (RUF). RUF may appear after radical prostatectomy. Their treatment represents a challenge; many therapies have been proposed, from conservative to aggressive surgical approaches. Transanal endoscopic surgery (TEO or TEM) is a minimally invasive technique to access the site of the RUF to perform repair. MATERIALS AND METHODS: This is an observational study with prospective data collection, conducted between September 2006 and December 2015. All patients were diagnosed with RUF following management of prostate cancer. Conservative treatment was administered in the form of urinary and fecal diversion with cystotomy and terminal colostomy, to achieve total urinary and fecal exclusion. If the fistula persisted, it was treated by TEO or TEM, with or without biological mesh interposition. If this failed, gracilis muscle was applied as salvage therapy. RESULTS: Ten patients were diagnosed with RUF. In 1 patient (1 of 10), the fistula healed with bladder catheterization alone. In another patient (1 of 9), it resolved after total urinary and fecal exclusion. Eight patients underwent repair by TEO or TEM, 4 with biological mesh interposition; all 4 presented recurrence. In the other 4 patients treated via TEO or TEM, 2 had early recurrence, whereas the others had healed at follow-up visits after 4-6 months (2 of 8)-a success rate of 25%. The 6 patients who recurred were treated with gracilis muscle interposition via a transperineal approach. CONCLUSION: The low rate of positive results obtained by TEO or TEM argues against its use as technique of choice in RUF, and against the use of biological meshes.",
      "provenance": [
        {
          "field": "population",
          "quote": "All patients were diagnosed with RUF following management of prostate cancer."
        },
        {
          "field": "intervention",
          "quote": "If the fistula persisted, it was treated by TEO or TEM, with or without biological mesh interposition."
        },
        {
          "field": "comparator",
          "quote": "Conservative treatment was administered in the form of urinary and fecal diversion with cystotomy and terminal colostomy, to achieve total urinary and fecal exclusion."
        },
        {
          "field": "primaryOutcome",
          "quote": "To assess the role of transanal endoscopic operation (TEO) or transanal endoscopic microsurgery (TEM) in rectourethral fistulas (RUF)."
        },
        {
          "field": "result",
          "quote": "In 1 patient (1 of 10), the fistula healed with bladder catheterization alone. In another patient (1 of 9), it resolved after total urinary and fecal exclusion."
        },
        {
          "field": "result",
          "quote": "a success rate of 25%"
        },
        {
          "field": "n",
          "quote": "Ten patients were diagnosed with RUF."
        },
        {
          "field": "followUp",
          "quote": "the others had healed at follow-up visits after 4-6 months"
        }
      ]
    },
    {
      "id": "pmid:28564707",
      "pmid": "28564707",
      "doi": "10.1055/s-0037-1603092",
      "nctId": null,
      "pmcid": null,
      "title": "Treatment of First-Time Perianal Abscess in Childhood, Balance Recurrence and Fistula Formation Rate with Medical Intervention",
      "firstAuthor": "Gong",
      "multipleAuthors": true,
      "journal": "Eur J Pediatr Surg",
      "year": 2018,
      "design": "retrospective",
      "n": 697,
      "nField": "reported",
      "population": "children with first-time perianal abscess",
      "intervention": "conservative (non-surgical) medical treatment",
      "comparator": "incision and drainage surgery",
      "primaryOutcome": "rate of recurrence and/or later fistula formation",
      "result": "conservative treatment had a lower recurrence/fistula rate than incision and drainage (12.7% vs 24.6%, p<0.001)",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "It is a retrospective study comparing treatments without randomization, so other differences between groups could explain the result.",
      "directness": "indirect",
      "limitations": "Retrospective design without randomization; abstract does not address healing of an already-formed fistula, only prevention of fistula after abscess.",
      "followUp": "395 days",
      "plainFinding": "Fewer fistulas with non-surgical abscess care.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/28564707/",
      "sourceText": "PURPOSE: Because of differences in therapy for first-time perianal abscess, a wide range of recurrences and/or development of fistula-in-ano (RF) rates have been reported. The indication for determining when surgical intervention is needed remains obscure and controversial. This retrospective study sought to compare outcomes of conservative treatment with those after incision and drainage (ID) to determine the optimal time for surgical intervention. METHODS: A total of 697 patients with first-time perianal abscess were included in this study. The median patient age at the time of onset was 129 days (range: 5-5,110 days). The median follow-up period was 395 days (range: 120-760 days). RESULTS: Of the 697 patients with first-time perianal abscess, 355 (50.9%) patients who received conservative treatment had 12.7% (45/355) RF rate, which is less than that of abscesses treated with ID (24.6%, 72/297; p < 0.001). The median course was 23 (2,466) days, which did not differ significantly from that of abscesses with ID (18 [3,510] days) (p = 0.609). Forty-six (6.6%) patients with abscesses that perforated spontaneously had 10.9% (5/46) RF rate, which was less than that of abscesses with ID (p = 0.019), and the median course was 9 (3,316) days, which was shorter than that of abscesses with ID (p = 0.04). CONCLUSION: Conservative treatment is a safe and effective technique for most first-time perianal abscesses with less recurrence and a lower fistula formation rate. Incision must be performed when an abscess is likely to spread or shows no sign of spontaneous perforation.",
      "provenance": [
        {
          "field": "n",
          "quote": "A total of 697 patients with first-time perianal abscess were included in this study."
        },
        {
          "field": "population",
          "quote": "A total of 697 patients with first-time perianal abscess were included in this study."
        },
        {
          "field": "intervention",
          "quote": "355 (50.9%) patients who received conservative treatment had 12.7% (45/355) RF rate"
        },
        {
          "field": "comparator",
          "quote": "which is less than that of abscesses treated with ID (24.6%, 72/297; p < 0.001)"
        },
        {
          "field": "primaryOutcome",
          "quote": "a wide range of recurrences and/or development of fistula-in-ano (RF) rates have been reported"
        },
        {
          "field": "result",
          "quote": "which is less than that of abscesses treated with ID (24.6%, 72/297; p < 0.001)"
        },
        {
          "field": "followUp",
          "quote": "The median follow-up period was 395 days (range: 120-760 days)."
        }
      ]
    },
    {
      "id": "pmid:28395390",
      "pmid": "28395390",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "Surgical Treatment of Rectovaginal Fistula in Crohn's Disease: A Tertiary Center Experience",
      "firstAuthor": "Milito",
      "multipleAuthors": true,
      "journal": "Surg Technol Int",
      "year": 2017,
      "design": "retrospective",
      "n": 43,
      "nField": "reported",
      "population": "women with rectovaginal fistula caused by Crohn's disease",
      "intervention": "surgical repair of the fistula using various techniques (seton, flap procedures, mesh, muscle flap)",
      "comparator": "different surgical techniques compared to each other (no non-surgical group)",
      "primaryOutcome": "whether the fistula healed after surgery",
      "result": "81% of patients healed after surgery, 19% failed, with a median time to success of six months",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This is a retrospective, uncontrolled case series from one center with no comparison to non-surgical treatment, so it can't show whether fistulas heal without surgery.",
      "directness": "indirect",
      "limitations": "Retrospective design, single surgeon/center, no control group, and focuses on rectovaginal fistula in Crohn's disease rather than general anal fistula or non-surgical management.",
      "followUp": "18 months",
      "plainFinding": "Most healed after surgery, none without it.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/28395390/",
      "sourceText": "BACKGROUND: Rectovaginal fistula (RVF) is a disastrous complication of Crohn's disease (CD) that is exceedingly difficult to treat. It is a disabling condition that negatively impacts a woman's quality of life. Current treatment algorithms range from observation to medical management to the need for surgical intervention. A wide variety of success rates have been reported for all management options. The choice of surgical repair methods depends on various fistula and patient characteristics, and its published success rates vary with initial success being around 50% rising to 80% with repeated surgery. Several surgical and sphincter sparing approaches have been described for the management of rectovaginal fistula, aimed to minimize the recurrence and to preserve the continence. MATERIALS AND METHODS: A retrospective study was performed for RVF repair between 2008 and 2014 in our tertiary centre at the University Hospital of Tor Vergata, Italy. All the patients were affected by Crohn's disease and underwent surgery for an RVF under the same senior surgeon. All patients were prospectively evaluated. RESULTS: All 43 patients that underwent surgery for RVF were affected by Crohn's disease. The median age was 43 years (range 21-53). Four different surgical approaches were performed: drainage and seton, rectal advacenment flap (RAF), vaginal advancement flap (VAF), transperineal approach using porcine dermal matrix (PDM), and martius flap (MF). The median time to success was six months (range 2-11). None of the patients were lost during the 18 months of follow-up. The failure group rate was 19% in contrast with the healing rate group that was 81%. No demographic of disease-related factors were found to influence healing. CONCLUSION: The case series of this study supports the dogma that \"there are no absolute rules when treating Crohn's fistula\". There is no gold standard technique; however, it is mandatory to minimize the recurrence with a sphincter saving technique. Randomized trials are needed to find a standard surgical approach.",
      "provenance": [
        {
          "field": "population",
          "quote": "Rectovaginal fistula (RVF) is a disastrous complication of Crohn's disease (CD)"
        },
        {
          "field": "n",
          "quote": "All 43 patients that underwent surgery for RVF were affected by Crohn's disease."
        },
        {
          "field": "intervention",
          "quote": "Four different surgical approaches were performed: drainage and seton, rectal advacenment flap (RAF), vaginal advancement flap (VAF), transperineal approach using porcine dermal matrix (PDM), and martius flap (MF)."
        },
        {
          "field": "comparator",
          "quote": "No demographic of disease-related factors were found to influence healing."
        },
        {
          "field": "primaryOutcome",
          "quote": "The failure group rate was 19% in contrast with the healing rate group that was 81%."
        },
        {
          "field": "result",
          "quote": "The median time to success was six months (range 2-11). None of the patients were lost during the 18 months of follow-up. The failure group rate was 19% in contrast with the healing rate group that was 81%."
        }
      ]
    },
    {
      "id": "pmid:28209416",
      "pmid": "28209416",
      "doi": "10.1016/j.jpedsurg.2017.01.062",
      "nctId": null,
      "pmcid": null,
      "title": "Efficacy of an anal fistula plug for fistulas-in-Ano in children",
      "firstAuthor": "Kouchi",
      "multipleAuthors": true,
      "journal": "J Pediatr Surg",
      "year": 2017,
      "design": "case-series",
      "n": 8,
      "nField": "reported",
      "population": "children with anal fistulas that didn't heal despite long-term conservative treatment",
      "intervention": "anal fistula plug (Surgisis Anal Fistula Plug) placed in the fistula tract",
      "comparator": "none (single-arm treatment study)",
      "primaryOutcome": "whether the fistula closed and healed",
      "result": "8 of 11 fistulas (72.7%) healed successfully; 3 recurred and required surgery (fistulectomy)",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "This was a small, uncontrolled case series of only 8 children, so it can't reliably show whether the plug works better than no treatment or surgery.",
      "directness": "indirect",
      "limitations": "No control group, very small number of patients, and the plug is not an approved device in the study's country, which may affect wider applicability.",
      "followUp": "",
      "plainFinding": "Fistula plug healed most pediatric fistulas.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/28209416/",
      "sourceText": "BACKGROUND: In children, perianal abscesses have a good prognosis and often heal with age. However, some perianal abscesses are refractory to treatment and remain as fistulas-in-Ano. Treatment with a Surgisis Anal Fistula Plug® has been reported as a new method of treatment for fistulas. In adults, the plug has been reported to cause little pain and have a high cure rate, but there have been no reported cases of its use in children. PURPOSE: This study was designed to analyze the efficacy of the plug for closure of refractory fistulas in children. METHODS: Since the plug has not been approved as a medical device in Japan, application for its use was submitted to the ethics committee of our university, and approval was granted, marking the first use of the plug in Japan. We classified refractory fistulas as those treated for 6months or longer and remaining unhealed, even after 1year of age, despite continued conservative treatment. The plug was used in 11 refractory fistulas in 8 children. RESULTS: Eight of 11 fistulas (72.7%) were successfully treated. Three fistulas recurred, and fistulectomies were performed. No sequelae were observed after AFP treatment. CONCLUSION: The plug was effective even for closure of refractory fistulas without sequelae in children. LEVELS OF EVIDENCE: Treatment Study, Level IV.",
      "provenance": [
        {
          "field": "population",
          "quote": "We classified refractory fistulas as those treated for 6months or longer and remaining unhealed, even after 1year of age, despite continued conservative treatment."
        },
        {
          "field": "intervention",
          "quote": "The plug was used in 11 refractory fistulas in 8 children."
        },
        {
          "field": "comparator",
          "quote": "The plug was used in 11 refractory fistulas in 8 children."
        },
        {
          "field": "primaryOutcome",
          "quote": "This study was designed to analyze the efficacy of the plug for closure of refractory fistulas in children."
        },
        {
          "field": "result",
          "quote": "Eight of 11 fistulas (72.7%) were successfully treated. Three fistulas recurred, and fistulectomies were performed."
        },
        {
          "field": "n",
          "quote": "The plug was used in 11 refractory fistulas in 8 children."
        }
      ]
    },
    {
      "id": "pmid:27663698",
      "pmid": "27663698",
      "doi": "10.1007/s10151-016-1536-1",
      "nctId": null,
      "pmcid": null,
      "title": "A systematic review of the management of anal fistula in infants",
      "firstAuthor": "Emile",
      "multipleAuthors": true,
      "journal": "Tech Coloproctol",
      "year": 2016,
      "design": "systematic-review",
      "n": 490,
      "nField": "reported",
      "population": "infants younger than 2 years old with anal fistula",
      "intervention": "conservative (non-surgical) treatment",
      "comparator": "surgical treatment (fistulotomy or fistulectomy)",
      "primaryOutcome": "complete resolution of the fistula and recurrence rate",
      "result": "About 20% of infants were treated conservatively first, and 73% of them had complete resolution without surgery",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This review pooled mostly small, non-randomized case series without a formal quality assessment, so the conservative-treatment findings are based on limited, less rigorous data.",
      "directness": "indirect",
      "limitations": "The review combines heterogeneous studies, and only a minority of infants received conservative treatment, limiting how confidently results generalize.",
      "followUp": "",
      "plainFinding": "Many infants healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/27663698/",
      "sourceText": "BACKGROUND: Fistula-in-ano (FIA) in infants differs, in several ways, from FIA in adults. The current review aims to assess FIA in infants less than 2 years old and to illustrate the outcome of different treatment modalities described in the literature. METHODS: An organized search of the English literature over the past 25 years was conducted according to the preferred reporting items for systematic reviews and meta-analyses guidelines. Electronic databases and Google Scholar were searched for articles focusing on management of FIA in infants. RESULTS: Fourteen studies were eligible for this review. Variables analyzed comprised patient characteristics, type of FIA, methods of treatment, recurrence, and postoperative complications. The studies included comprised total of 490 infants, 89 % of them less than 1 year old. Most patients (97.5 %) were males with a median age of 7 months. Around 20 % of patients with FIA underwent conservative treatment initially, and 73 % of them achieved complete resolution. Surgery was performed on 86 % of the infants. Fistulotomy accounted for 65 % of the procedures performed and was associated with a higher recurrence rate than fistulectomy (6.6 vs. 1.1 %, respectively). Complications of surgical management occurred in 2.6 % of the patients. FIA typically occurs in male infants, mainly under 1 year of age. Almost all fistulae in this age group are low. CONCLUSIONS: The majority of the studies reviewed evaluated surgical treatment of FIA. However, the few studies that employed conservative treatment reported complete resolution of FIA in most infants. Fistulotomy was the most commonly performed surgery for FIA and was associated with fewer complications, yet a higher recurrence rate than fistulectomy.",
      "provenance": [
        {
          "field": "population",
          "quote": "FIA in infants less than 2 years old"
        },
        {
          "field": "n",
          "quote": "total of 490 infants"
        },
        {
          "field": "intervention",
          "quote": "Around 20 % of patients with FIA underwent conservative treatment initially"
        },
        {
          "field": "comparator",
          "quote": "Surgery was performed on 86 % of the infants."
        },
        {
          "field": "primaryOutcome",
          "quote": "Variables analyzed comprised patient characteristics, type of FIA, methods of treatment, recurrence, and postoperative complications."
        },
        {
          "field": "result",
          "quote": "73 % of them achieved complete resolution"
        }
      ]
    },
    {
      "id": "pmid:27466166",
      "pmid": "27466166",
      "doi": "10.1097/MCG.0000000000000607",
      "nctId": null,
      "pmcid": null,
      "title": "A Systematic Review Assessing Medical Treatment for Rectovaginal and Enterovesical Fistulae in Crohn's Disease",
      "firstAuthor": "Kaimakliotis",
      "multipleAuthors": true,
      "journal": "J Clin Gastroenterol",
      "year": 2016,
      "design": "systematic-review",
      "n": 181,
      "nField": "reported",
      "population": "people with Crohn's disease who have rectovaginal or enterovesical fistulas",
      "intervention": "medical therapy (including anti-TNF drugs), alone or combined with surgery",
      "comparator": "no formal comparison group; rates compared across different treatment approaches (medical alone, anti-TNF, medical plus surgery)",
      "primaryOutcome": "whether the fistula fully closed, partly closed, or did not respond",
      "result": "fistulas closed completely in some patients but many had no response, with better closure rates for enterovesical than rectovaginal fistulas",
      "resultDirection": "mixed",
      "quality": "low",
      "qualityWhy": "the review combined many small, low-quality studies without a control group, so the findings are not very reliable.",
      "directness": "indirect",
      "limitations": "abstract states studies were small and of low quality, with no consensus on management and a call for larger, better studies",
      "followUp": "",
      "plainFinding": "Some fistulas closed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/27466166/",
      "sourceText": "BACKGROUND: Rectovaginal and enterovesical fistulae are difficult to treat in patients with Crohn's disease. Currently, there is no consensus regarding their appropriate management. AIM OF THE STUDY: The aim of the study was to review the literature on the medical management of rectovaginal and enterovesical fistulae in Crohn's disease and to assess their response to treatment. METHOD: A literature search of MEDLINE, EMBASE, Science Citation Index Expanded, and Cochrane was performed. RESULTS: Twenty-three studies were identified, reporting on 137 rectovaginal and 44 enterovesical fistulae. The overall response rates of rectovaginal fistulae to medical therapy were: 38.3% complete response (fistula closure), 22.3% partial response, and 39.4% no response. For enterovesical fistulae the response rates to medical therapy were: 65.9% complete response, 20.5% partial response, and 13.6% no response. Specifically, response to anti-tumor necrosis factor therapy of 78 rectovaginal fistulae was: 41.0% complete response, 21.8% partial response, and 37.2% no response. Response of 14 enterovesical fistulae to anti-tumor necrosis factor therapy was: 57.1% complete response, 35.7% partial response, and 7.1% no response. The response to a combination of medical and surgical therapy in 43 rectovaginal fistulae was: 44.2% complete response, 20.9% partial response, and 34.9% no response. CONCLUSIONS: Medical therapy, alone or in combination with surgery, appears to benefit some patients with rectovaginal or enterovesical fistula. However, given the small size and low quality of the published studies, it is still difficult to draw conclusions regarding treatment. Larger, better quality studies are required to assess response to medical treatment and evaluate indications for surgery.",
      "provenance": [
        {
          "field": "population",
          "quote": "patients with Crohn's disease"
        },
        {
          "field": "intervention",
          "quote": "medical management of rectovaginal and enterovesical fistulae in Crohn's disease"
        },
        {
          "field": "comparator",
          "quote": "The response to a combination of medical and surgical therapy in 43 rectovaginal fistulae was: 44.2% complete response, 20.9% partial response, and 34.9% no response."
        },
        {
          "field": "primaryOutcome",
          "quote": "to assess their response to treatment"
        },
        {
          "field": "result",
          "quote": "The overall response rates of rectovaginal fistulae to medical therapy were: 38.3% complete response (fistula closure), 22.3% partial response, and 39.4% no response. For enterovesical fistulae the response rates to medical therapy were: 65.9% complete response, 20.5% partial response, and 13.6% no response."
        },
        {
          "field": "n",
          "quote": "Twenty-three studies were identified, reporting on 137 rectovaginal and 44 enterovesical fistulae."
        },
        {
          "field": "limitations",
          "quote": "given the small size and low quality of the published studies, it is still difficult to draw conclusions regarding treatment"
        }
      ]
    },
    {
      "id": "pmid:27354199",
      "pmid": "27354199",
      "doi": "10.1111/jog.13066",
      "nctId": null,
      "pmcid": null,
      "title": "Rectovaginal fistula: Twenty years of rectovaginal repair",
      "firstAuthor": "Lo",
      "multipleAuthors": true,
      "journal": "J Obstet Gynaecol Res",
      "year": 2016,
      "design": "retrospective",
      "n": 397,
      "nField": "reported",
      "population": "women diagnosed with rectovaginal fistula at a Taiwan hospital",
      "intervention": "conservative (non-surgical) treatment",
      "comparator": "surgical repair (simple repair or reconstruction)",
      "primaryOutcome": "improved outcome at 12 months after treatment",
      "result": "56 patients (14.1%) had conservative treatment and 341 (85.9%) had surgery; overall 344 patients (86.7%) had improved outcome at 12 months, and the authors concluded surgery is the preferred option while medical treatment should be used only for small fistulas or unsuitable surgical candidates",
      "resultDirection": "mixed",
      "quality": "low",
      "qualityWhy": "This is a retrospective review of rectovaginal (not anal) fistulas that does not directly compare healing rates between conservative and surgical treatment, so it only weakly and indirectly informs the question.",
      "directness": "indirect",
      "limitations": "Retrospective design, no direct statistical comparison of outcomes between conservative and surgical groups, and the population studied (rectovaginal fistula) differs from anal fistula.",
      "followUp": "12 months",
      "plainFinding": "Most fistulas needed surgery to heal.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/27354199/",
      "sourceText": "AIM: To identify the favorable factors in rectovaginal fistula (RVF) management. METHODS: After Institutional Review Board approval (99-0793B), we retrospectively studied all patients diagnosed, treated and followed up with RVF at Chang Gung Memorial Hospital, Taiwan between January 1990 and December 2009. All female patients with International Classification of Diseases RVF were included. We reviewed demographic data, socioeconomic status, clinical presentation, comorbidities, method of treatment, duration of hospitalization and clinical outcome at 12 months postoperatively. RESULTS: A total of 397 patients were included in the study. Fifty-six patients (14.1%) had conservative treatment and 341 patients (85.9%) underwent surgical intervention. A total of 125 patients underwent simple repair while 216 patients underwent reconstruction. Three hundred and forty-four patients (86.7%) had improved outcome at 12-month follow up. Age (P = 0.003), education level (P = 0.033), ability to pay insurance (P < 0.001), and choice of treatment (P < 0.0001) were identified as significant favorable factors. An etiological factor associated with favorable outcome was RVF from obstetric complication, while that resulting from malignancy had a less favorable outcome. CONCLUSIONS: Age, education level and ability to pay insurance significantly affect 12-month outcome of RVF. Surgery is the preferred option, while medical treatment should be used only for small rectovaginal fistulas or for patients not suitable for surgery and anesthesia. More support and assistance should be offered to those patients with unfavorable factors, such as old age, low education level and inability to afford insurance. All RVF secondary to obstetrical injury had a 100% favorable outcome compared with those secondary to surgery or malignancy. Women with suspected RVF should receive prompt and extensive evaluation to ensure immediate effective management and prevention of further serious complications.",
      "provenance": [
        {
          "field": "population",
          "quote": "All female patients with International Classification of Diseases RVF were included."
        },
        {
          "field": "n",
          "quote": "A total of 397 patients were included in the study."
        },
        {
          "field": "intervention",
          "quote": "Fifty-six patients (14.1%) had conservative treatment"
        },
        {
          "field": "comparator",
          "quote": "341 patients (85.9%) underwent surgical intervention"
        },
        {
          "field": "primaryOutcome",
          "quote": "clinical outcome at 12 months postoperatively"
        },
        {
          "field": "result",
          "quote": "Three hundred and forty-four patients (86.7%) had improved outcome at 12-month follow up."
        },
        {
          "field": "result",
          "quote": "Surgery is the preferred option, while medical treatment should be used only for small rectovaginal fistulas or for patients not suitable for surgery and anesthesia."
        }
      ]
    },
    {
      "id": "pmid:26878185",
      "pmid": "26878185",
      "doi": "10.3928/00904481-20160113-02",
      "nctId": null,
      "pmcid": null,
      "title": "Recurrent Pediatric Perianal Swelling",
      "firstAuthor": "Cordova",
      "multipleAuthors": true,
      "journal": "Pediatr Ann",
      "year": 2016,
      "design": "narrative-review",
      "n": null,
      "nField": "not-reported",
      "population": "children with Crohn's disease and perianal complications",
      "intervention": "medicines that calm inflammation (immunomodulators and biologics) plus surgery",
      "comparator": "not clearly compared, general treatment approach described",
      "primaryOutcome": "treating perianal Crohn's disease including fistulas and abscesses",
      "result": "guidelines recommend combining surgery with medication, not medication alone",
      "resultDirection": "unclear",
      "quality": "very-low",
      "qualityWhy": "this is a general review and case report discussion, not a study testing whether fistulas heal without surgery.",
      "directness": "indirect",
      "limitations": "abstract does not report a specific study, data, or outcomes comparing surgery versus no surgery; it is a general review of pediatric perianal Crohn's disease.",
      "followUp": "",
      "plainFinding": "Recommends combining surgery and medicine.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/26878185/",
      "sourceText": "Pediatric inflammatory bowel disease is a chronic gastrointestinal disease consisting of Crohn's disease (CD) and ulcerative colitis (UC). Both disease processes can share similar clinical symptoms including abdominal pain, diarrhea, hematochezia, and weight loss; CD can also be complicated by penetrating and fistulizing disease. Perianal skin tags, perianal abscesses, recto-cutaneous fistulae, and rectal stenosis are among the phenotypic characteristics of perianal CD. Current treatment strategies are focused on the surgical drainage of abscesses and the closure of fistulous tracts as well as controlling intestinal inflammation with the use of immunomodulators (6-mercaptopurine and methotrexate) and biologics (infliximab and adalimumab). Current guidelines by the American Gastroenterology Association and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition recommend a combination of surgical intervention and medical management for the treatment of perianal CD.",
      "provenance": [
        {
          "field": "population",
          "quote": "Pediatric inflammatory bowel disease is a chronic gastrointestinal disease consisting of Crohn's disease (CD) and ulcerative colitis (UC)."
        },
        {
          "field": "intervention",
          "quote": "controlling intestinal inflammation with the use of immunomodulators (6-mercaptopurine and methotrexate) and biologics (infliximab and adalimumab)"
        },
        {
          "field": "comparator",
          "quote": "Current treatment strategies are focused on the surgical drainage of abscesses and the closure of fistulous tracts"
        },
        {
          "field": "primaryOutcome",
          "quote": "treatment of perianal CD"
        },
        {
          "field": "result",
          "quote": "Current guidelines by the American Gastroenterology Association and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition recommend a combination of surgical intervention and medical management for the treatment of perianal CD."
        }
      ]
    },
    {
      "id": "pmid:26603576",
      "pmid": "26603576",
      "doi": "10.1111/codi.13223",
      "nctId": null,
      "pmcid": null,
      "title": "Allogeneic adipose-derived stem cells for the treatment of perianal fistula in Crohn's disease: a pilot clinical trial",
      "firstAuthor": "Park",
      "multipleAuthors": true,
      "journal": "Colorectal Dis",
      "year": 2016,
      "design": "case-series",
      "n": 6,
      "nField": "reported",
      "population": "People with Crohn's disease who have a fistula near the anus",
      "intervention": "Injection of donor (allogeneic) fat-derived stem cells into the fistula, at two different doses",
      "comparator": "No comparison group; the two dose groups were compared to each other",
      "primaryOutcome": "Complete closure of the fistula by 8 weeks after injection",
      "result": "3 of 6 patients had complete fistula closure (two by 4-6 months, one by 8 weeks); no serious treatment-related side effects",
      "resultDirection": "mixed",
      "quality": "very-low",
      "qualityWhy": "This was a tiny, uncontrolled pilot study in only 6 patients with no comparison group, so it cannot show whether the treatment itself caused the healing.",
      "directness": "indirect",
      "limitations": "Very small sample size, no control group, open-label design, and dose-escalation pilot structure limit conclusions about effectiveness.",
      "followUp": "8 weeks, with additional follow-up to 6 months and up to month 8 for responders",
      "plainFinding": "Some fistulas healed without surgery here.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/26603576/",
      "sourceText": "AIM: Many perianal fistulae in Crohn's disease do not respond to conventional surgical and medical management and recurrence rates are high. The study evaluated the safety and feasibility of allogeneic adipose-derived stem cells for the treatment of perianal fistula in Crohn's disease. METHOD: A multicentre, open-label, dose escalation pilot study was performed. The first three patients (group 1) were administered 1 × 10(7) cells/ml based on the size of the fistula tract. Four weeks later, after which time this dose had been confirmed to be safe, the next three patients (group 2) were administered 3 × 10(7) cells/ml. The end-point was complete closure at 8 weeks after the injection. Patients who attended for the 8 week assessment were followed for an additional 6 months. RESULTS: There were no adverse events of Grade 3 or 4 severity and no adverse events related to the treatment with allogeneic adipose-derived stem cells. Two patients in group 1 achieved complete closure of the fistula at month 4 and month 6, and one patient in group 2 achieved complete closure at 8 weeks. The closure was sustained up to month 8 in all three of those patients. CONCLUSION: These data suggest that allogeneic adipose-derived stem cells may be a feasible treatment option for perianal fistula in Crohn's disease.",
      "provenance": [
        {
          "field": "n",
          "quote": "The first three patients (group 1) were administered 1 × 10(7) cells/ml"
        },
        {
          "field": "population",
          "quote": "perianal fistula in Crohn's disease"
        },
        {
          "field": "intervention",
          "quote": "allogeneic adipose-derived stem cells for the treatment of perianal fistula in Crohn's disease"
        },
        {
          "field": "comparator",
          "quote": "The first three patients (group 1) were administered 1 × 10(7) cells/ml based on the size of the fistula tract. Four weeks later, after which time this dose had been confirmed to be safe, the next three patients (group 2) were administered 3 × 10(7) cells/ml."
        },
        {
          "field": "primaryOutcome",
          "quote": "The end-point was complete closure at 8 weeks after the injection."
        },
        {
          "field": "result",
          "quote": "Two patients in group 1 achieved complete closure of the fistula at month 4 and month 6, and one patient in group 2 achieved complete closure at 8 weeks."
        },
        {
          "field": "result",
          "quote": "There were no adverse events of Grade 3 or 4 severity and no adverse events related to the treatment with allogeneic adipose-derived stem cells."
        }
      ]
    },
    {
      "id": "pmid:24436656",
      "pmid": "24436656",
      "doi": "10.1055/s-0033-1348047",
      "nctId": null,
      "pmcid": "PMC3709961",
      "title": "Surgical treatment of anorectal crohn disease",
      "firstAuthor": "Lewis",
      "multipleAuthors": true,
      "journal": "Clin Colon Rectal Surg",
      "year": 2013,
      "design": "narrative-review",
      "n": null,
      "nField": "not-reported",
      "population": "people with Crohn disease who have anal/perineal fistulas",
      "intervention": "surgical repair options for fistula-in-ano (fistulotomy, fibrin glue, anal fistula plug, flap, LIFT)",
      "comparator": "non-surgical management (drainage, seton, medical therapy) or no treatment",
      "primaryOutcome": "successful fistula healing/closure",
      "result": "Surgical repair methods all show reduced effectiveness in Crohn disease patients, and in active disease only drainage and seton placement are advised, not definitive repair",
      "resultDirection": "mixed",
      "quality": "low",
      "qualityWhy": "This is a narrative review discussing treatment options without original data, patient numbers, or controlled comparisons.",
      "directness": "direct",
      "limitations": "No original study data, no patient numbers, no control group, purely descriptive review of surgical options.",
      "followUp": "",
      "plainFinding": "Surgery often less effective in Crohn's.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/24436656/",
      "sourceText": "Crohn disease involves the perineum and rectum in approximately one-third of patients. Symptoms can range from mild, including skin tags and hemorrhoids, to unremitting and severe, requiring a proctectomy in a small, but significant, portion. Fistula-in-ano and perineal sepsis are the most frequent manifestation seen on presentation. Careful diagnosis, including magnetic resonance imaging or endorectal ultrasound with examination under anesthesia and aggressive medical management, usually with a tumor necrosis factor-alpha, is critical to success. Several options for definitive surgical repair are discussed, including fistulotomy, fibrin glue, anal fistula plug, endorectal advancement flap, and ligation of intersphincteric fistula tract procedure. All suffer from decreased efficacy in patients with Crohn disease. In the presence of active proctitis or perineal disease, no surgical therapy other than drainage of abscesses and loose seton placement is recommended, as iatrogenic injury and poor wound healing are common in that scenario.",
      "provenance": [
        {
          "field": "population",
          "quote": "Crohn disease involves the perineum and rectum in approximately one-third of patients."
        },
        {
          "field": "intervention",
          "quote": "Several options for definitive surgical repair are discussed, including fistulotomy, fibrin glue, anal fistula plug, endorectal advancement flap, and ligation of intersphincteric fistula tract procedure."
        },
        {
          "field": "comparator",
          "quote": "In the presence of active proctitis or perineal disease, no surgical therapy other than drainage of abscesses and loose seton placement is recommended"
        },
        {
          "field": "primaryOutcome",
          "quote": "Fistula-in-ano and perineal sepsis are the most frequent manifestation seen on presentation."
        },
        {
          "field": "result",
          "quote": "All suffer from decreased efficacy in patients with Crohn disease."
        }
      ]
    },
    {
      "id": "pmid:23525574",
      "pmid": "23525574",
      "doi": "10.1136/gutjnl-2013-304488",
      "nctId": null,
      "pmcid": null,
      "title": "Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: a randomised, double-blind, placebo controlled trial (ADAFI)",
      "firstAuthor": "Dewint",
      "multipleAuthors": true,
      "journal": "Gut",
      "year": 2014,
      "design": "rct",
      "n": 76,
      "nField": "reported",
      "population": "adults with Crohn's disease and active perianal fistulas",
      "intervention": "adalimumab plus ciprofloxacin",
      "comparator": "adalimumab plus placebo",
      "primaryOutcome": "50% reduction in draining fistulas at 12 weeks",
      "result": "71% responded to combination therapy vs 47% to adalimumab alone at week 12, but no difference remained at week 24",
      "resultDirection": "mixed",
      "quality": "moderate",
      "qualityWhy": "It was a well-designed randomized, double-blind, placebo-controlled trial, but it was fairly small and the early benefit did not last after stopping the antibiotic.",
      "directness": "indirect",
      "limitations": "Small sample size (76 patients); benefit of combination therapy was not maintained after antibiotic discontinuation; population limited to Crohn's disease fistulas rather than general anal fistula population.",
      "followUp": "24 weeks",
      "plainFinding": "Fistulas healed with drug therapy, not surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/23525574/",
      "sourceText": "OBJECTIVE: To assess whether a combination of adalimumab and ciprofloxacin is superior to adalimumab alone in the treatment of perianal fistulising Crohn's disease (CD). DESIGN: Randomised, double-blind, placebo controlled trial in eight Dutch hospitals. In total, 76 CD patients with active perianal fistulising disease were enrolled. After adalimumab induction therapy (160/80 mg week 0, 2), patients received 40 mg every other week together with ciprofloxacin 500 mg or placebo twice daily for 12 weeks. After 12 weeks, adalimumab was continued. Follow-up was 24 weeks. Primary endpoint (clinical response) was defined as 50% reduction of fistulas from baseline to week 12. Secondary endpoints included remission (closure of all fistulas), Perianal Crohn's Disease Activity Index, Crohn's Disease Activity Index (CDAI) and Inflammatory Bowel Disease Questionnaire (IBDQ). RESULTS: Clinical response was observed in 71% of patients treated with adalimumab plus ciprofloxacin and in 47% treated with adalimumab plus placebo (p=0.047). Likewise, remission rate at week 12 was significantly higher (p=0.009) in the combination group (65%) compared with adalimumab plus placebo (33%). Combination treatment was associated with a higher mean CDAI change and mean IBDQ change at week 12 (p=0.005 and p=0.009, respectively). At week 24, no difference in clinical response between the two treatment groups was observed (p=0.22). No difference in safety issues was observed. CONCLUSIONS: Combination therapy of adalimumab and ciprofloxacin is more effective than adalimumab monotherapy to achieve fistula closure in CD. However, after discontinuation of antibiotic therapy, the beneficial effect of initial coadministration is not maintained. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00736983.",
      "provenance": [
        {
          "field": "population",
          "quote": "76 CD patients with active perianal fistulising disease were enrolled"
        },
        {
          "field": "intervention",
          "quote": "patients received 40 mg every other week together with ciprofloxacin 500 mg"
        },
        {
          "field": "comparator",
          "quote": "adalimumab plus placebo"
        },
        {
          "field": "primaryOutcome",
          "quote": "Primary endpoint (clinical response) was defined as 50% reduction of fistulas from baseline to week 12."
        },
        {
          "field": "result",
          "quote": "Clinical response was observed in 71% of patients treated with adalimumab plus ciprofloxacin and in 47% treated with adalimumab plus placebo (p=0.047)."
        },
        {
          "field": "result",
          "quote": "At week 24, no difference in clinical response between the two treatment groups was observed (p=0.22)."
        },
        {
          "field": "n",
          "quote": "In total, 76 CD patients with active perianal fistulising disease were enrolled."
        },
        {
          "field": "followUp",
          "quote": "Follow-up was 24 weeks."
        }
      ]
    },
    {
      "id": "pmid:23480921",
      "pmid": "23480921",
      "doi": "10.1016/j.jpedsurg.2012.11.029",
      "nctId": null,
      "pmcid": null,
      "title": "Repair of fistulae in-ano in children using image guided Histoacryl injection after failure of conservative treatment",
      "firstAuthor": "Osman",
      "multipleAuthors": true,
      "journal": "J Pediatr Surg",
      "year": 2013,
      "design": "case-series",
      "n": 30,
      "nField": "reported",
      "population": "children and infants with perianal fistula who had already tried conservative treatment",
      "intervention": "injection of tissue glue (N Butyl Cyanoacrylate/Histoacryl) into the fistula tract under imaging guidance",
      "comparator": "no formal comparison group; some patients instead had standard surgery",
      "primaryOutcome": "whether the fistula closed up (healed)",
      "result": "16 of 17 patients (94%) treated with the glue injection had their fistula close, though 2 had it come back and needed repeat injection",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This was a small, uncontrolled group of patients without randomization or a comparison group, so it can't firmly prove the glue caused the healing.",
      "directness": "indirect",
      "limitations": "Small sample size, no control group, no randomization, and the successful group was a subset of a larger mixed population.",
      "followUp": "18 months",
      "plainFinding": "Fistula healed without surgery in most children.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/23480921/",
      "sourceText": "PURPOSE: Our aim is to determine the feasibility and safety of N Butyl Cyanoacrylate (HISTOACRYL), adhesive material in the treatment of fistula in-ano in infants and children. PATIENTS AND METHODS: 30 patients who presented with a perianal fistula (25 males and 5 females) were studied. Their ages ranged from 9 months to 15 years. All patients received medical (conservative) treatment. Six patients improved, 7 patients were subjected to surgical intervention, and the remaining 17 patients were managed by injection of adhesive material through the fistula under fluoroscopic guidance and general anesthesia after failure of medical management. RESULTS: Of the 17 children who underwent injection therapy to the fistula in-ano after failed medical management, 14 patients were males. The procedure time was 10 to 15 min. The mean follow up was 18 months. Two patients had a recurrence after one to two months. They were subjected to reinjection, and one of them had a second recurrence. Overall, 16 (94%) of 17 patients have had successful closure of their fistula, and one of them healed from a second injection. CONCLUSION: Our method of tissue adhesive Cyanoacrylate injection is safe, feasible, and can be used repeatedly in treatment of fistula in-ano in infants and children.",
      "provenance": [
        {
          "field": "n",
          "quote": "30 patients who presented with a perianal fistula (25 males and 5 females) were studied"
        },
        {
          "field": "population",
          "quote": "infants and children"
        },
        {
          "field": "intervention",
          "quote": "injection of adhesive material through the fistula under fluoroscopic guidance and general anesthesia after failure of medical management"
        },
        {
          "field": "comparator",
          "quote": "7 patients were subjected to surgical intervention"
        },
        {
          "field": "primaryOutcome",
          "quote": "successful closure of their fistula"
        },
        {
          "field": "result",
          "quote": "16 (94%) of 17 patients have had successful closure of their fistula, and one of them healed from a second injection"
        }
      ]
    },
    {
      "id": "pmid:23347777",
      "pmid": "23347777",
      "doi": "10.1016/j.ejso.2013.01.001",
      "nctId": null,
      "pmcid": null,
      "title": "Contemporary management of perianal conditions in febrile neutropenic patients",
      "firstAuthor": "Morcos",
      "multipleAuthors": true,
      "journal": "Eur J Surg Oncol",
      "year": 2013,
      "design": "retrospective",
      "n": 933,
      "nField": "reported",
      "population": "adult patients with fever and low white blood cell counts (from chemotherapy) who had perianal problems",
      "intervention": "conservative (non-surgical) management of perianal conditions",
      "comparator": "surgical drainage or debridement",
      "primaryOutcome": "management approach and outcome (including death) of septic perianal conditions",
      "result": "only 4 of 26 septic perianal conditions were fistulas, and the abstract does not separately report how these fistulas were treated or whether they healed; overall, surgery was mainly reserved for collections and most patients without a collection were managed conservatively",
      "resultDirection": "unclear",
      "quality": "very-low",
      "qualityWhy": "this is a small retrospective chart review in cancer patients with low white blood cell counts, with only 4 fistula cases and no fistula-specific outcomes reported, so it cannot reliably answer whether fistulas heal without surgery.",
      "directness": "indirect",
      "limitations": "Retrospective review; very small number of fistula patients (4); no separate outcome data for fistulas; population is febrile neutropenic (cancer/chemotherapy) patients, not the general population with anal fistula.",
      "followUp": "",
      "plainFinding": "Fistula outcomes not specifically reported.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/23347777/",
      "sourceText": "INTRODUCTION: The aim of this study was to examine the type and frequency of perianal conditions in a contemporary series of febrile neutropenic patients and to examine the risk factors, management options and outcome of septic perianal conditions. METHODS: Medical records of all adult febrile neutropenic patients (933 patients) who were admitted during the period from January, 2009 to December 2011 were retrospectively review. All patients with perianal complaints or conditions were included. The clinical features, management and outcome of septic conditions were recorded. RESULTS: Of all the reviewed charts, 101 (10.8%) had perianal complaints or conditions. Most of them were non septic (74.3%), like piles and fissures, and were treated conservatively. In 26 patients the diagnosis was a septic condition: abscess (12 patients), fistula (4), inflammation (9) and necrotizing fasciitis (1). Septic conditions were more commonly found in males younger than 40 years. Surgery was done in 13 patients to drain a collection and in 2 patients to debride necrotic tissue. Most patients who had no collection had conservative management. There was 1 fatality only (3.8%) in those 26 patients. CONCLUSION: Most of the perianal conditions in febrile neutropenic patients are non septic and are managed conservatively. Septic perianal conditions are not associated with a poor prognosis as in the past. Surgical drainage should be reserved to conditions where there is a collection; otherwise patients should be managed conservatively but with close monitoring.",
      "provenance": [
        {
          "field": "n",
          "quote": "933 patients"
        },
        {
          "field": "population",
          "quote": "adult febrile neutropenic patients"
        },
        {
          "field": "intervention",
          "quote": "Most patients who had no collection had conservative management."
        },
        {
          "field": "comparator",
          "quote": "Surgery was done in 13 patients to drain a collection and in 2 patients to debride necrotic tissue."
        },
        {
          "field": "primaryOutcome",
          "quote": "the risk factors, management options and outcome of septic perianal conditions"
        },
        {
          "field": "result",
          "quote": "abscess (12 patients), fistula (4), inflammation (9) and necrotizing fasciitis (1)"
        },
        {
          "field": "result",
          "quote": "Surgical drainage should be reserved to conditions where there is a collection; otherwise patients should be managed conservatively but with close monitoring."
        }
      ]
    },
    {
      "id": "pmid:23315048",
      "pmid": "23315048",
      "doi": "10.1007/s11605-012-2126-9",
      "nctId": null,
      "pmcid": null,
      "title": "Fistula-in-ano: when to cut, tie, plug, or sew",
      "firstAuthor": "Beaulieu",
      "multipleAuthors": true,
      "journal": "J Gastrointest Surg",
      "year": 2013,
      "design": "narrative-review",
      "n": null,
      "nField": "not-reported",
      "population": "people with anal fistula (fistula-in-ano)",
      "intervention": "different surgical techniques for treating anal fistula",
      "comparator": "non-surgical (conservative) management of anal fistula",
      "primaryOutcome": "healing of the wound and ability to control bowel movements after treatment",
      "result": "the abstract states that medical management often fails with high recurrence, leading patients to need surgical care, but gives no specific outcome data",
      "resultDirection": "unclear",
      "quality": "very-low",
      "qualityWhy": "This is a surgeon's practice overview and opinion piece, not a study with measured outcomes or a control group.",
      "directness": "indirect",
      "limitations": "No original data, no defined outcomes, numbers, or comparison group; describes general surgical practice and techniques rather than a study.",
      "followUp": "",
      "plainFinding": "Non-surgical care often fails, surgery usually needed.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/23315048/",
      "sourceText": "INTRODUCTION: Management of fistula-in-ano requires understanding of both perianal and rectal anatomy, as well as the surgical approaches available to ensure the highest possible postoperative continence and wound healing. Further, high rates of recurrence with medical management commonly bring these patients under the care of the colorectal surgeon after variable periods of failed conservative management. Novel techniques provide surgeons with tools to treat increasingly complex fistulas with a focus on maintaining sphincteric functionality and limiting recurrence. METHOD: This manuscript presents our practice, including perioperative decision making regarding surgical approach, in managing patients with fistula-in-ano. CONCLUSION: Familiarity with these techniques prepares the general surgeon and colorectal surgeon to improve wound healing and functional outcomes in these patients, especially with complex disease involving the external and internal anal sphincters.",
      "provenance": [
        {
          "field": "population",
          "quote": "managing patients with fistula-in-ano"
        },
        {
          "field": "intervention",
          "quote": "surgical approaches available to ensure the highest possible postoperative continence and wound healing"
        },
        {
          "field": "comparator",
          "quote": "failed conservative management"
        },
        {
          "field": "primaryOutcome",
          "quote": "postoperative continence and wound healing"
        },
        {
          "field": "result",
          "quote": "high rates of recurrence with medical management commonly bring these patients under the care of the colorectal surgeon after variable periods of failed conservative management"
        }
      ]
    },
    {
      "id": "pmid:23179514",
      "pmid": "23179514",
      "doi": "10.1007/s00104-012-2297-7",
      "nctId": null,
      "pmcid": null,
      "title": "[Perianal fistula and anal fissure]",
      "firstAuthor": "Heitland",
      "multipleAuthors": false,
      "journal": "Chirurg",
      "year": 2012,
      "design": "narrative-review",
      "n": null,
      "nField": "not-reported",
      "population": "people with anal fistula caused by gland infection",
      "intervention": "no treatment / conservative options like fibrin glue or plug",
      "comparator": "surgical operation",
      "primaryOutcome": "whether the fistula heals and whether incontinence develops",
      "result": "perianal fistulas do not heal on their own; treatment ranges from surgery to conservative options like fibrin glue or plug",
      "resultDirection": "harm",
      "quality": "low",
      "qualityWhy": "this is a narrative review summarizing opinion rather than presenting original study data or evidence quality.",
      "directness": "direct",
      "limitations": "no study design, sample size, or data presented; abstract gives general clinical statements only",
      "followUp": "",
      "plainFinding": "Fistulas don't heal without treatment.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/23179514/",
      "sourceText": "CRYPTOGLANDULAR ANAL FISTULA: Perianal abscesses are caused by cryptoglandular infections. Not every abscess will end in a fistula. The formation of a fistula is determined by the anatomy of the anal sphincter and perianal fistulas will not heal on their own. The therapy of a fistula is oriented between a more aggressive approach (operation) and a conservative treatment with fibrin glue or a plug. Definitive healing and the development of incontinence are the most important key points. ANAL FISSURES: Acute anal fissures should be treated conservatively by topical ointments, consisting of nitrates, calcium channel blockers and if all else fails by botulinum toxin. Treatment of chronic fissures will start conservatively but operative options are necessary in many cases. Operation of first choice is fissurectomy, including excision of fibrotic margins, curettage of the base and excision of the sentinel pile and anal polyps. Lateral internal sphincterotomy is associated with a certain degree of incontinence and needs critical long-term observation.",
      "provenance": [
        {
          "field": "population",
          "quote": "Perianal abscesses are caused by cryptoglandular infections"
        },
        {
          "field": "intervention",
          "quote": "a conservative treatment with fibrin glue or a plug"
        },
        {
          "field": "comparator",
          "quote": "a more aggressive approach (operation)"
        },
        {
          "field": "primaryOutcome",
          "quote": "Definitive healing and the development of incontinence are the most important key points"
        },
        {
          "field": "result",
          "quote": "perianal fistulas will not heal on their own"
        }
      ]
    },
    {
      "id": "pmid:23144340",
      "pmid": "23144340",
      "doi": "10.1136/bcr.03.2012.6115",
      "nctId": null,
      "pmcid": "PMC3624664",
      "title": "Conservative treatment of a recto-urethral fistula due to salvage HIFU for local recurrence of prostate cancer, 5 years after radical prostatectomy and external beam radiotherapy",
      "firstAuthor": "Topazio",
      "multipleAuthors": true,
      "journal": "BMJ Case Rep",
      "year": 2012,
      "design": "case-series",
      "n": 1,
      "nField": "reported",
      "population": "68-year-old man with a recto-urethral fistula after prostate cancer treatment (HIFU, prior prostatectomy and radiotherapy)",
      "intervention": "conservative treatment with an indwelling Foley catheter, no surgery",
      "comparator": "no intestinal diversion surgery was performed",
      "primaryOutcome": "whether the fistula healed or recurred over follow-up",
      "result": "no recurrence of the fistula was found 24 months after treatment",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "this is a single patient case report, so it cannot show what usually happens or rule out chance.",
      "directness": "indirect",
      "limitations": "single case, fistula caused by HIFU/radiotherapy for prostate cancer rather than typical anal fistula disease",
      "followUp": "24 months",
      "plainFinding": "Healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": true,
      "url": "https://pubmed.ncbi.nlm.nih.gov/23144340/",
      "sourceText": "Recto-urethral fistula is one of the most serious complications caused by high-intensity-focused ultrasound used as salvage treatment for recurrence of prostate cancer after brachytherapy or external beam radiotherapy (EBRT). We report the case of a recto-urethral fistula in a 68-year-old patient, who previously had undergone radical prostatectomy and EBRT for prostate cancer (pT3 N0 Mx). The fistula was treated conservatively by an indwelling Foley catheter, without the creation of an intestinal diversion. The fistula was assessed initially by a retrograde and a CT scan of the pelvis with contrast medium and reassessed periodically by means of retrograde urethrograms. To date, 24 months after this episode, no evidence of recurrence of the fistula has been found.",
      "provenance": [
        {
          "field": "n",
          "quote": "a 68-year-old patient"
        },
        {
          "field": "population",
          "quote": "We report the case of a recto-urethral fistula in a 68-year-old patient, who previously had undergone radical prostatectomy and EBRT for prostate cancer"
        },
        {
          "field": "intervention",
          "quote": "The fistula was treated conservatively by an indwelling Foley catheter, without the creation of an intestinal diversion."
        },
        {
          "field": "comparator",
          "quote": "without the creation of an intestinal diversion"
        },
        {
          "field": "primaryOutcome",
          "quote": "reassessed periodically by means of retrograde urethrograms"
        },
        {
          "field": "result",
          "quote": "To date, 24 months after this episode, no evidence of recurrence of the fistula has been found."
        }
      ]
    },
    {
      "id": "pmid:22964807",
      "pmid": "22964807",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "Fistula plug versus conventional surgical treatment for anal fistulas. A system review and meta-analysis",
      "firstAuthor": "Pu",
      "multipleAuthors": true,
      "journal": "Saudi Med J",
      "year": 2012,
      "design": "meta-analysis",
      "n": 428,
      "nField": "reported",
      "population": "patients with anal fistulas",
      "intervention": "fistula plug treatment",
      "comparator": "conventional surgical treatment",
      "primaryOutcome": "fistula coming back (recurrence) and fecal incontinence",
      "result": "fistula plug had a higher recurrence rate than surgery (62.1% versus 47%), with no significant difference in incontinence between the two",
      "resultDirection": "harm",
      "quality": "low",
      "qualityWhy": "Only 2 randomized trials and 3 retrospective studies with 428 patients total, so results are not very reliable.",
      "directness": "direct",
      "limitations": "Abstract does not report study heterogeneity, follow-up duration, or risk of bias assessment.",
      "followUp": "",
      "plainFinding": "Plug heals worse than surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/22964807/",
      "sourceText": "OBJECTIVE: To evaluate the recurrence and fecal incontinence of anal fistula plug versus conventional surgical treatment for anal fistulas. METHODS: This meta-analysis was carried out in the General Surgery Department of the Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China. We searched the Medline, EMBASE, and Cochrane Library from June 2011 to April 2012. The literature searches were carried out using medical subject headings and free-text word: anal fistula, fibrin adhesive, fibrin sealant, and fistula plug. RESULTS: Two randomized controlled trials and 3 retrospective controlled studies were included. A total of 428 patients were included in our study. The recurrence rate was higher in those patients who accept fistula plug treatment (62.1% versus 47%) (p=0.004). CONCLUSION: Anal fistula plug has a moderate probability of success with little risk of incontinence, but the recurrence rate is significantly higher than the conventional surgical treatment. This treatment is minimally invasive, repeatable, and sphincter-sparing. This meta-analysis failed to find a statistically significant difference in incontinence rate between conservative treatment and conventional surgical treatment.",
      "provenance": [
        {
          "field": "n",
          "quote": "A total of 428 patients were included in our study."
        },
        {
          "field": "population",
          "quote": "anal fistulas"
        },
        {
          "field": "intervention",
          "quote": "anal fistula plug"
        },
        {
          "field": "comparator",
          "quote": "conventional surgical treatment"
        },
        {
          "field": "primaryOutcome",
          "quote": "To evaluate the recurrence and fecal incontinence of anal fistula plug versus conventional surgical treatment for anal fistulas."
        },
        {
          "field": "result",
          "quote": "The recurrence rate was higher in those patients who accept fistula plug treatment (62.1% versus 47%) (p=0.004)."
        },
        {
          "field": "result",
          "quote": "This meta-analysis failed to find a statistically significant difference in incontinence rate between conservative treatment and conventional surgical treatment."
        }
      ]
    },
    {
      "id": "pmid:22867866",
      "pmid": "22867866",
      "doi": "10.1016/j.mehy.2012.07.015",
      "nctId": null,
      "pmcid": null,
      "title": "Argentum-quarz solution in the treatment of anorectal fistulas: is it possible a conservative approach?",
      "firstAuthor": "Tomasello",
      "multipleAuthors": true,
      "journal": "Med Hypotheses",
      "year": 2012,
      "design": "narrative-review",
      "n": null,
      "nField": "not-reported",
      "population": "Patients with anorectal fistulas, often linked to Crohn's disease, Ulcerative Colitis, or Indeterminate Colitis",
      "intervention": "Argentum-quarz (silver and quartz) solution applied to the fistula as a conservative treatment",
      "comparator": "Standard surgical treatment, and fibrin glue as an alternative conservative approach",
      "primaryOutcome": "Potential healing of anorectal fistulas without surgery",
      "result": "The paper proposes and discusses a theoretical mechanism by which silver and quartz could help heal fistulas, without presenting clinical outcome data",
      "resultDirection": "unclear",
      "quality": "very-low",
      "qualityWhy": "This is a theoretical/hypothesis paper with no patient data or clinical results reported.",
      "directness": "indirect",
      "limitations": "The abstract describes only a proposed hypothesis and discussion of a therapeutic mechanism; it reports no actual patients, trial, or measured outcomes.",
      "followUp": "",
      "plainFinding": "No clinical data, just a hypothesis.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/22867866/",
      "sourceText": "Patients suffering from chronic intestinal diseases (Crohn's disease, Ulcerative Colitis, Indeterminate Colitis) are prone to the development of pyogenic complications. These complications are most commonly in the form of perianal or intraabdominal abscesses and/or fistulas. The treatment of these complications are managed differently but, after an initial treatment based on medical or minimally invasive management, the solution of the pathological condition is always achieved by a surgical procedure. In the last few years prospective studies have proposed an alternative conservative therapeutic approach based on application of fibrin glue in the healing of patients with fistulas-in-ano. In this paper we suggest and discuss the therapeutic potential of silver and quarz in the conservative treatment of anorectal fistulas pointing out their role in modulating particular steps of the pathogenetic process which characterizes this pathological condition.",
      "provenance": [
        {
          "field": "population",
          "quote": "Patients suffering from chronic intestinal diseases (Crohn's disease, Ulcerative Colitis, Indeterminate Colitis) are prone to the development of pyogenic complications."
        },
        {
          "field": "intervention",
          "quote": "the therapeutic potential of silver and quarz in the conservative treatment of anorectal fistulas"
        },
        {
          "field": "comparator",
          "quote": "prospective studies have proposed an alternative conservative therapeutic approach based on application of fibrin glue in the healing of patients with fistulas-in-ano"
        },
        {
          "field": "primaryOutcome",
          "quote": "we suggest and discuss the therapeutic potential of silver and quarz in the conservative treatment of anorectal fistulas pointing out their role in modulating particular steps of the pathogenetic process"
        },
        {
          "field": "result",
          "quote": "In this paper we suggest and discuss the therapeutic potential of silver and quarz in the conservative treatment of anorectal fistulas pointing out their role in modulating particular steps of the pathogenetic process which characterizes this pathological condition."
        }
      ]
    },
    {
      "id": "pmid:22476123",
      "pmid": "22476123",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "[Experience with a biological plug for biological in complex anal fistula]",
      "firstAuthor": "Borda Mederos",
      "multipleAuthors": true,
      "journal": "Rev Gastroenterol Peru",
      "year": 2011,
      "design": "case-series",
      "n": 46,
      "nField": "reported",
      "population": "patients with complex anorectal fistula, most with previous surgery",
      "intervention": "biological plug (Surgisis AFP) placed in the fistula tract without surgery",
      "comparator": "no concurrent comparison group; historical comparison with other fistula techniques",
      "primaryOutcome": "closure/success of the fistula without recurrence",
      "result": "the plug closed the fistula successfully in about 74% of patients over a median follow-up of nearly 2.5 years, with no incontinence reported",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "it is a retrospective review of one treatment group without a comparison arm, so it cannot prove the plug works better than surgery.",
      "directness": "direct",
      "limitations": "retrospective design, no control group, single-center case review",
      "followUp": "29.8 months",
      "plainFinding": "Plug healed most fistulas, no incontinence.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/22476123/",
      "sourceText": "Treatment of complex anal fistula is a surgical challenge because the risk of sphincter injury with the possibility of developing fecal incontinence. There are many techniques for the treatment of anal fistulas such as fistulotomy, fistulectomy, seton, endorectal advancement flap and fibrin glue, with different rates of recurrence and fecal incontinence. The biologic plug Surgisis® AFP it's being used since 2006 and produces the closure of the fistula in approximately 12 weeks, without surgery, by replacement of the fistulous tract by cells of the patient, apparently having advantages over other techniques.We retrospectively reviewed the results of 46 patients with complex anorectal fistula treated with the biological plug over a period of 4 years. Of these, 34 were men (73.9%) and 12 women, the mean age was 47.2 years. According the type of fistula, 41 were recurrent fistulas (89.1%) and 5 high transsphincteric fistulas (10.8%). Patients underwent surgery on average 2.2 times previously. The anal fistula plug was successful in 73.9% of cases with a median follow-up 29.8 months. Use of anal fistula plug Surgisis® AFP is a new alternative with acceptable results in terms of recurrence comparable to other techniques, but with no incontinence.",
      "provenance": [
        {
          "field": "n",
          "quote": "We retrospectively reviewed the results of 46 patients with complex anorectal fistula treated with the biological plug over a period of 4 years."
        },
        {
          "field": "population",
          "quote": "41 were recurrent fistulas (89.1%) and 5 high transsphincteric fistulas (10.8%)"
        },
        {
          "field": "intervention",
          "quote": "The biologic plug Surgisis® AFP it's being used since 2006 and produces the closure of the fistula in approximately 12 weeks, without surgery"
        },
        {
          "field": "comparator",
          "quote": "Use of anal fistula plug Surgisis® AFP is a new alternative with acceptable results in terms of recurrence comparable to other techniques, but with no incontinence."
        },
        {
          "field": "primaryOutcome",
          "quote": "The anal fistula plug was successful in 73.9% of cases with a median follow-up 29.8 months."
        },
        {
          "field": "result",
          "quote": "The anal fistula plug was successful in 73.9% of cases with a median follow-up 29.8 months."
        }
      ]
    },
    {
      "id": "pmid:22379401",
      "pmid": "22379401",
      "doi": "10.1055/s-0031-1272819",
      "nctId": null,
      "pmcid": "PMC3140329",
      "title": "Anorectal infection: abscess-fistula",
      "firstAuthor": "Abcarian",
      "multipleAuthors": false,
      "journal": "Clin Colon Rectal Surg",
      "year": 2011,
      "design": "narrative-review",
      "n": null,
      "nField": "not-reported",
      "population": "adults with anorectal abscess or fistula",
      "intervention": "surgical treatment of anal fistula (various techniques)",
      "comparator": "different surgical approaches to each other (sphincter-cutting vs conservative)",
      "primaryOutcome": "cure of fistula versus fecal incontinence and recurrence",
      "result": "the abstract states fistula treatment is surgical in all cases, with conservative (non-sphincter-cutting) procedures resulting in more recurrence or persistence requiring repeat operations",
      "resultDirection": "unclear",
      "quality": "low",
      "qualityWhy": "this is a narrative review of general treatment approaches without original patient data or controlled comparison, so it cannot reliably establish whether fistulas heal without surgery.",
      "directness": "direct",
      "limitations": "no original data, no specific numbers of patients, no controlled comparison, author opinion-based review",
      "followUp": "",
      "plainFinding": "Surgery always needed, says review.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/22379401/",
      "sourceText": "Anorectal abscess and fistula are among the most common diseases encountered in adults. Abscess and fistula should be considered the acute and chronic phase of the same anorectal infection. Abscesses are thought to begin as an infection in the anal glands spreading into adjacent spaces and resulting in fistulas in ~40% of cases. The treatment of an anorectal abscess is early, adequate, dependent drainage. The treatment of a fistula, although surgical in all cases, is more complex due to the possibility of fecal incontinence as a result of sphincterotomy. Primary fistulotomy and cutting setons have the same incidence of fecal incontinence depending on the complexity of the fistula. So even though the aim of a surgical procedure is to cure a fistula, conservative management short of major sphincterotomy is warranted to preserve fecal incontinence. However, trading radical surgery for conservative (nonsphincter cutting) procedures such as a draining seton, fibrin sealant, anal fistula plug, endorectal advancement flap, dermal island flap, anoplasty, and LIFT (ligation of intersphincteric fistula tract) procedure all result in more recurrence/persistence requiring repeated operations in many cases. A surgeon dealing with fistulas on a regular basis must tailor various operations to the needs of the patient depending on the complexity of the fistula encountered.",
      "provenance": [
        {
          "field": "population",
          "quote": "Anorectal abscess and fistula are among the most common diseases encountered in adults."
        },
        {
          "field": "intervention",
          "quote": "The treatment of a fistula, although surgical in all cases, is more complex due to the possibility of fecal incontinence as a result of sphincterotomy."
        },
        {
          "field": "comparator",
          "quote": "trading radical surgery for conservative (nonsphincter cutting) procedures such as a draining seton, fibrin sealant, anal fistula plug, endorectal advancement flap, dermal island flap, anoplasty, and LIFT (ligation of intersphincteric fistula tract) procedure all result in more recurrence/persistence requiring repeated operations in many cases"
        },
        {
          "field": "primaryOutcome",
          "quote": "So even though the aim of a surgical procedure is to cure a fistula, conservative management short of major sphincterotomy is warranted to preserve fecal incontinence."
        },
        {
          "field": "result",
          "quote": "The treatment of a fistula, although surgical in all cases, is more complex due to the possibility of fecal incontinence as a result of sphincterotomy."
        }
      ]
    },
    {
      "id": "pmid:22070555",
      "pmid": "22070555",
      "doi": "10.1186/1471-230X-11-120",
      "nctId": null,
      "pmcid": "PMC3235969",
      "title": "Surgery for fistula-in-ano in a specialist colorectal unit: a critical appraisal",
      "firstAuthor": "Sileri",
      "multipleAuthors": true,
      "journal": "BMC Gastroenterol",
      "year": 2011,
      "design": "prospective-cohort",
      "n": 247,
      "nField": "reported",
      "population": "adults with anal fistulas (mostly from infection, some from Crohn's disease or ulcerative colitis)",
      "intervention": "surgical treatment (fistulotomy, fistulectomy, seton placement, or rectal flap)",
      "comparator": "different surgical techniques compared to each other, not to no surgery",
      "primaryOutcome": "whether the fistula healed and whether incontinence occurred",
      "result": "61% of patients had their fistula tract eradicated with surgery, and only 2.4% had incontinence",
      "resultDirection": "unclear",
      "quality": "low",
      "qualityWhy": "this is a single-center case series of surgical patients with no non-surgical comparison group, so it cannot show whether fistulas heal without surgery.",
      "directness": "indirect",
      "limitations": "No randomization, no comparison to non-surgical management, and the abstract itself calls for high-quality randomized trials.",
      "followUp": "6 months",
      "plainFinding": "",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/22070555/",
      "sourceText": "BACKGROUND: Several techniques have been described for the management of fistula-in-ano, but all carry their own risks of recurrence and incontinence. We conducted a prospective study to assess type of presentation, treatment strategy and outcome over a 5-year period. METHODS: Between 1st January 2005 and 31st March 2011,247 patients presenting with anal fistulas were treated at the University Hospital Tor Vergata and were included in the present prospective study. Mean age was 47 years (range 16-76 years); minimum follow-up period was 6 months (mean 40, range 6-74 months).Patients were treated using 4 operative approaches: fistulotomy, fistulectomy, seton placement and rectal advancement flap. Data analyzed included: age, gender, type of fistula, operative intervention, healing rate, postoperative complications, reinterventions and recurrence. RESULTS: Etiologies of fistulas were cryptoglandular (n = 218), Crohn's disease (n = 26) and Ulcerative Colitis (n = 3). Fistulae were classified as simple -intersphincteric 57 (23%), low transphincteric 28 (11%) and complex -high transphicteric 122 (49%), suprasphincteric 2 (0.8%), extrasphinteric 2 (0.8%), recto-vaginal 7 (2.8%) Crohn 26 (10%) and UC 3 (1.2%).The most common surgical procedure was the placement of seton (62%), usually applied in case of complex fistulae and Crohn's patients.Eighty-five patients (34%) underwent fistulotomy, mainly for intersphincteric and mid/low transphincteric tracts. Crohn's patients were submitted to placement of one or more loose setons.The main treatment successfully eradicated the primary fistula tract in 151/247 patients (61%). Three cases of major incontinence (1.3%) were detected during the follow-up period; Furthermore, three patients complained minor incontinence that was successfully treated by biofeedback and permacol injection into the internal anal sphincter. CONCLUSIONS: This prospective audit demonstrates an high proportion of complex anal fistulae treated by seton placement that was the most common surgical technique adopted to treat our patients as a first line. Nevertheless, a good outcome was achieved in the majority of patients with a limited rate of faecal incontinence (6/247 = 2.4%). New technologies provide promising alternatives to traditional methods of management particularly in case of complex fistulas. There is, however, a real need for high-quality randomized control trials to evaluate the different surgical and non surgical treatment options.",
      "provenance": [
        {
          "field": "n",
          "quote": "247 patients presenting with anal fistulas were treated"
        },
        {
          "field": "population",
          "quote": "247 patients presenting with anal fistulas were treated at the University Hospital Tor Vergata"
        },
        {
          "field": "intervention",
          "quote": "Patients were treated using 4 operative approaches: fistulotomy, fistulectomy, seton placement and rectal advancement flap."
        },
        {
          "field": "comparator",
          "quote": "Data analyzed included: age, gender, type of fistula, operative intervention, healing rate, postoperative complications, reinterventions and recurrence."
        },
        {
          "field": "primaryOutcome",
          "quote": "The main treatment successfully eradicated the primary fistula tract in 151/247 patients (61%)"
        },
        {
          "field": "result",
          "quote": "The main treatment successfully eradicated the primary fistula tract in 151/247 patients (61%). Three cases of major incontinence (1.3%) were detected during the follow-up period"
        },
        {
          "field": "followUp",
          "quote": "minimum follow-up period was 6 months (mean 40, range 6-74 months)"
        }
      ]
    },
    {
      "id": "pmid:21785979",
      "pmid": "21785979",
      "doi": "10.1007/s00383-011-2956-7",
      "nctId": null,
      "pmcid": null,
      "title": "Perianal abscess and fistula-in-ano in children: clinical characteristic, management and outcome",
      "firstAuthor": "Afşarlar",
      "multipleAuthors": true,
      "journal": "Pediatr Surg Int",
      "year": 2011,
      "design": "retrospective",
      "n": 158,
      "nField": "reported",
      "population": "children with perianal abscess or anal fistula",
      "intervention": "non-surgical management (drainage, local care, with or without antibiotics)",
      "comparator": "surgical treatment (fistulotomy or fistulectomy)",
      "primaryOutcome": "whether the anal fistula healed on its own or needed surgery",
      "result": "9 of 52 fistulas healed without surgery; the other 43 needed surgical treatment",
      "resultDirection": "mixed",
      "quality": "low",
      "qualityWhy": "This was a retrospective chart review without a control group, so the comparison between spontaneous healing and surgery isn't a fair test.",
      "directness": "indirect",
      "limitations": "Retrospective design, no randomization or control group, and the study is in children, who may differ from adults with anal fistula.",
      "followUp": "10.6 ± 8.6 months",
      "plainFinding": "Few fistulas healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/21785979/",
      "sourceText": "PURPOSE: The aims of this study are to evaluate the clinical characteristics of perianal abscess and fistula-in-ano in children, and to assess our experience in treatment, and to identify factors that affected the clinical outcomes. METHODS: A retrospective review of children with perianal abscess and fistula-in-ano was carried out in a tertiary care children's hospital from January 2005 to December 2010. Demographic information of the patients, localization of the lesions, treatment procedures, microbial organisms in pus, usage of antibiotics, abscess recurrence, development of fistula-in-ano, and duration of symptoms were recorded. Patients with systemic diseases and inflammatory bowel diseases were excluded from the study. RESULTS: A total of 158 children (146 males, 12 females) treated for perianal abscess and fistula-in-ano with a median age of 7.2 months (ranging 16 days to 18 years) were eligible for the study. Initial examination of the 136 patients revealed perianal abscess and 22 patients with fistula-in-ano. Primary treatment was incision and drainage (I/D) for the fluctuating perianal abscess (73.5%), and local care for the spontaneously (S/D) drained abscess (26.5%) with or without antibiotic therapy. Patients were divided into two groups according to age distribution, 98 of the patients were younger than 12 months, and 60 were older than 12 months of age. There was no significant difference in sex distribution, localization of the lesions, treatment procedures, recurrence of abscess and fistula-in-ano formation between the two age groups (p > 0.05). Recurrence rates (27% in I/D and 30.6% in S/D, p > 0.05) and development of fistula-in-ano (20% in I/D and 27.8 in S/D, p > 0.05) were not significant I/D and S/D groups. Kind of the microorganisms in pus swaps did not effect the fistula-in-ano formation. Usage of antibiotics significantly reduced the development of fistula-in-ano (p = 0.001), but did not effect the recurrence of perianal abscess (p > 0.05). The mean follow-up period was 10.6 ± 8.6 months. While the 9 of the overall 52 fistula-in-ano (22 initial, 30 after abscess treatment) were resolved spontaneously, 43 of the remaining needed surgical intervention (fistulotomy/fistulectomy). CONCLUSIONS: Although management of perianal abscess is still controversial, simple drainage of the perianal abscess with additional antibiotic therapy reduces the development of fistula-in-ano. Fistula-in-ano within children has a chance of spontaneous resolution thus the immediate surgical intervention should be avoided.",
      "provenance": [
        {
          "field": "n",
          "quote": "A total of 158 children (146 males, 12 females) treated for perianal abscess and fistula-in-ano"
        },
        {
          "field": "population",
          "quote": "children with perianal abscess and fistula-in-ano"
        },
        {
          "field": "intervention",
          "quote": "local care for the spontaneously (S/D) drained abscess (26.5%) with or without antibiotic therapy"
        },
        {
          "field": "comparator",
          "quote": "43 of the remaining needed surgical intervention (fistulotomy/fistulectomy)"
        },
        {
          "field": "primaryOutcome",
          "quote": "development of fistula-in-ano"
        },
        {
          "field": "result",
          "quote": "While the 9 of the overall 52 fistula-in-ano (22 initial, 30 after abscess treatment) were resolved spontaneously, 43 of the remaining needed surgical intervention (fistulotomy/fistulectomy)."
        },
        {
          "field": "followUp",
          "quote": "The mean follow-up period was 10.6 ± 8.6 months."
        }
      ]
    },
    {
      "id": "pmid:21215427",
      "pmid": "21215427",
      "doi": "10.1016/j.urology.2010.10.028",
      "nctId": null,
      "pmcid": null,
      "title": "Rectourethral fistula after high-intensity focused ultrasound therapy for prostate cancer and its surgical management",
      "firstAuthor": "Netsch",
      "multipleAuthors": true,
      "journal": "Urology",
      "year": 2011,
      "design": "retrospective",
      "n": 8,
      "nField": "reported",
      "population": "men who developed a fistula between the rectum and urethra after high-intensity focused ultrasound treatment for prostate cancer",
      "intervention": "conservative (non-surgical) treatment of the fistula",
      "comparator": "major surgical repair (e.g., flap interposition, bowel resection)",
      "primaryOutcome": "whether the fistula healed without surgery",
      "result": "Conservative treatment failed in all patients, and all required major surgery to close the fistula",
      "resultDirection": "no-benefit",
      "quality": "very-low",
      "qualityWhy": "This is a small, retrospective series of a rare complication in a different type of fistula (urinary-rectal, not anal), with no comparison group.",
      "directness": "indirect",
      "limitations": "Retrospective design, very small number of cases, single condition-specific fistula type, no control group, possible selection bias in reporting treatment failures.",
      "followUp": "50.45 ± 25.07 months",
      "plainFinding": "Fistulas did not heal without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/21215427/",
      "sourceText": "OBJECTIVES: To report 8 cases of rectourethral fistula (RUF) in patients treated with high-intensity focused ultrasound (HIFU) for either localized or locally recurrent prostate cancer (PCa). METHODS: A retrospective analysis of 363 consecutive patients with PCa who underwent HIFU from 2002 to 2010 was done. One HIFU session was performed in 341 patients with localized PCa. Two HIFU sessions were performed in 22 patients. Salvage HIFU was performed in 22 patients after radiotherapy. RESULTS: A total of 8 patients (2.2%) developed RUF. Their mean age was 69.38 ± 6.19 years (range 61-78). The mean follow-up was 50.45 ± 25.07 months (range 25 to 84). The mean interval between HIFU and the development of RUF was 3 ± 0.93 weeks (range 1-4). RUF occurred within 4 weeks after 1 HIFU session (n = 4; 1.17%), 4 weeks after a repeated HIFU session (n = 3; 13.63%), and 3 weeks after salvage HIFU (n = 1; 4.54%). The mean fistula size was 9 ± 7.13 mm (range 3-25). Conservative treatment failed in all patients. Of the 8 patients, 4 underwent radical prostatectomy, with an omentum flap interposition, 3 received a gracilis interposition flap, performed transanally because of a small lesion (<10Ch) or perineally, and 1 underwent radical prostatectomy, rectal resection, and creation of a colonic J-pouch. CONCLUSIONS: The results of our study have shown that RUF is a rare, but severe, complication after 1 HIFU session (1.17%) for localized PCa. The occurrence of RUF after salvage HIFU (4.5%) and repeated HIFU sessions (13.63%) was markedly elevated. Spontaneous closure of RUF will not occur, requiring major abdominal surgery for definitive repair.",
      "provenance": [
        {
          "field": "population",
          "quote": "8 cases of rectourethral fistula (RUF) in patients treated with high-intensity focused ultrasound (HIFU) for either localized or locally recurrent prostate cancer (PCa)"
        },
        {
          "field": "intervention",
          "quote": "Conservative treatment failed in all patients."
        },
        {
          "field": "comparator",
          "quote": "4 underwent radical prostatectomy, with an omentum flap interposition, 3 received a gracilis interposition flap"
        },
        {
          "field": "primaryOutcome",
          "quote": "Conservative treatment failed in all patients."
        },
        {
          "field": "result",
          "quote": "Spontaneous closure of RUF will not occur, requiring major abdominal surgery for definitive repair."
        },
        {
          "field": "n",
          "quote": "A total of 8 patients (2.2%) developed RUF."
        },
        {
          "field": "followUp",
          "quote": "The mean follow-up was 50.45 ± 25.07 months (range 25 to 84)."
        }
      ]
    },
    {
      "id": "pmid:20850628",
      "pmid": "20850628",
      "doi": "10.1016/j.jpedsurg.2010.03.021",
      "nctId": null,
      "pmcid": null,
      "title": "Clinical characteristics and treatment of perianal abscess and fistula-in-ano in infants",
      "firstAuthor": "Chang",
      "multipleAuthors": true,
      "journal": "J Pediatr Surg",
      "year": 2010,
      "design": "retrospective",
      "n": 112,
      "nField": "reported",
      "population": "infant boys with perianal abscess and fistula-in-ano",
      "intervention": "conservative (non-surgical) treatment",
      "comparator": "surgical fistulectomy",
      "primaryOutcome": "cure of the perianal abscess/fistula",
      "result": "86.6% of infants were cured with conservative treatment, while 10.7% needed surgery and none of those recurred after surgery",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "It's a single-surgeon retrospective review without a comparison group, so it can't firmly prove conservative treatment is better than surgery.",
      "directness": "indirect",
      "limitations": "Retrospective design, single surgeon, no control group, and study limited to infants rather than the general population with anal fistula.",
      "followUp": "23.7 ± 11.7 months",
      "plainFinding": "Most infants healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/20850628/",
      "sourceText": "PURPOSE: The aims of this study were to evaluate the clinical characteristics of perianal abscess and fistula-in-ano in infants and to identify factors that affected the clinical outcomes. METHOD: The authors retrospectively reviewed the clinical data of 112 infants who were treated for perianal abscess and fistula-in-ano by a single pediatric surgeon from January 2006 to December 2008. RESULTS: All patients were male and the mean age of infants presented to our hospital was 6.0 ± 4.5 months. One hundred one patients (90.2%) had 1 or 2 perianal lesions, and 76 (67.9%) had lesions at the 3 and/or 9-o'clock directions. The use of oral antibiotics did not improve or aggravate the lesions in 29 of 37 cases. Ninety-seven patients (86.6%) were cured by conservative treatment with a mean duration of 5.2 ± 3.9 months from the onset of the disease to the cure. The mean age of curing was 9.0 ± 4.9 months. Feeding formula change showed improvement of stooling in 38 (62.3%) of 61 patients but did not affect the duration of conservative treatment. Multiple linear analysis revealed that the presence of multiple lesions was a significant independent variable (P = .001) for the duration of conservative treatment, but age of the onset and location of the lesion were not. Twelve patients (10.7%) underwent fistulectomy at a mean age of 15.0 ± 5.1 months. None of the patients had recurrences after operation for the mean follow-up period of 23.7 ± 11.7 months. CONCLUSION: Conservative treatment of perianal abscess and fistula-in-ano has an excellent outcome and could be the first choice of treatment of these diseases.",
      "provenance": [
        {
          "field": "population",
          "quote": "112 infants who were treated for perianal abscess and fistula-in-ano"
        },
        {
          "field": "intervention",
          "quote": "conservative treatment"
        },
        {
          "field": "comparator",
          "quote": "underwent fistulectomy"
        },
        {
          "field": "primaryOutcome",
          "quote": "cured by conservative treatment"
        },
        {
          "field": "result",
          "quote": "Ninety-seven patients (86.6%) were cured by conservative treatment with a mean duration of 5.2 ± 3.9 months from the onset of the disease to the cure."
        },
        {
          "field": "result",
          "quote": "Twelve patients (10.7%) underwent fistulectomy at a mean age of 15.0 ± 5.1 months. None of the patients had recurrences after operation"
        },
        {
          "field": "n",
          "quote": "112 infants who were treated for perianal abscess and fistula-in-ano"
        },
        {
          "field": "followUp",
          "quote": "mean follow-up period of 23.7 ± 11.7 months"
        }
      ]
    },
    {
      "id": "pmid:20105258",
      "pmid": "20105258",
      "doi": "10.1111/j.1440-1754.2009.01644.x",
      "nctId": null,
      "pmcid": null,
      "title": "Perianal abscess and fistula-in-ano in children: aetiology, management and outcome",
      "firstAuthor": "Ezer",
      "multipleAuthors": true,
      "journal": "J Paediatr Child Health",
      "year": 2010,
      "design": "case-series",
      "n": 39,
      "nField": "reported",
      "population": "children with perianal abscess and/or fistula-in-ano",
      "intervention": "non-surgical treatment (incision and drainage with or without antibiotics, or antibiotics alone)",
      "comparator": "surgical treatment (fistulotomy or fistulectomy)",
      "primaryOutcome": "whether the fistula healed or needed surgery, and recurrence after treatment",
      "result": "most children who had non-surgical treatment for abscess went on to develop a fistula, and most fistulas needed surgery, with some recurring even after a first operation",
      "resultDirection": "no-benefit",
      "quality": "low",
      "qualityWhy": "this is a small, retrospective review of patients from one hospital with no comparison group, so it can't reliably show whether non-surgical care works.",
      "directness": "direct",
      "limitations": "retrospective design, small sample, some patients lost to follow-up, no control group comparing treatments directly",
      "followUp": "",
      "plainFinding": "Mostly needed surgery to heal.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/20105258/",
      "sourceText": "AIM: We aimed to assess our experience in treatment and outcome of perianal abscess and/or fistula-in-ano in children. METHOD: The patients who were treated for perianal abscess and/or fistula-in-ano from January 2000 to December 2005 were included. Age, sex, duration of symptoms, number and site of the perianal abscess and/or fistula-in-ano, treatment modality and recurrences were recorded. RESULTS: The study consisted of 39 patients (36 boys) with a mean age of 29 +/- 49.1 months. At first examination the diagnosis was perianal abscess in 20 patients, perianal abscess with fistula in five patients and fistula-in-ano in 14 patients. No patients had an underlying illness. The primary local treatment of perianal abscess with or without fistula was incision and drainage (with or without antibiotic therapy) in 21 patients, and local care with antibiotic therapy was given to four patients. Of 20 patients with perianal abscess, 17 developed fistula-in-ano and three healed. One patient in the perianal abscess group who developed fistula-in-ano and two patients in the fistula group were lost to follow-up. Thirty-three patients with fistula-in-ano underwent surgical treatment either through a fistulotomy or through a fistulectomy. Five (15.1%) patients who experienced recurrent fistula-in-ano underwent fistulotomy were completely cured after the second operation. CONCLUSION: Treatment of a perianal abscess either through incision and drainage with antibiotics or through antibiotics alone resulted in a high rate (85%) of fistula formation. Fistula-in-ano can be treated either by fistulotomy or by fistulectomy, both of which are associated with a reasonable chance of recurrence of fistula-in-ano formation. We obtained good results in our patients through surgical approach (fistulotomy or fistulectomy), for fistula-in-ano formed following treatment of perianal abscess.",
      "provenance": [
        {
          "field": "n",
          "quote": "The study consisted of 39 patients (36 boys)"
        },
        {
          "field": "population",
          "quote": "perianal abscess and/or fistula-in-ano in children"
        },
        {
          "field": "intervention",
          "quote": "local care with antibiotic therapy was given to four patients"
        },
        {
          "field": "comparator",
          "quote": "underwent surgical treatment either through a fistulotomy or through a fistulectomy"
        },
        {
          "field": "primaryOutcome",
          "quote": "treatment modality and recurrences were recorded"
        },
        {
          "field": "result",
          "quote": "Of 20 patients with perianal abscess, 17 developed fistula-in-ano and three healed."
        },
        {
          "field": "result",
          "quote": "Thirty-three patients with fistula-in-ano underwent surgical treatment either through a fistulotomy or through a fistulectomy."
        },
        {
          "field": "result",
          "quote": "Five (15.1%) patients who experienced recurrent fistula-in-ano underwent fistulotomy were completely cured after the second operation."
        }
      ]
    },
    {
      "id": "pmid:20018317",
      "pmid": "20018317",
      "doi": "10.1016/j.juro.2009.10.020",
      "nctId": null,
      "pmcid": null,
      "title": "Incidence, clinical symptoms and management of rectourethral fistulas after radical prostatectomy",
      "firstAuthor": "Thomas",
      "multipleAuthors": true,
      "journal": "J Urol",
      "year": 2010,
      "design": "retrospective",
      "n": 13,
      "nField": "reported",
      "population": "men who developed a rectourethral fistula after surgery to remove the prostate for cancer",
      "intervention": "conservative (non-surgical) management of the fistula, sometimes with a temporary colostomy",
      "comparator": "colostomy with or without surgical closure, or immediate surgical closure without colostomy",
      "primaryOutcome": "whether the fistula closed (healed)",
      "result": "all 3 patients treated conservatively healed without surgery; with colostomy 3 of 9 closed spontaneously while 6 of 9 needed surgery (all successful); surgery without colostomy failed in the 1 patient who had it",
      "resultDirection": "mixed",
      "quality": "very-low",
      "qualityWhy": "This is a small retrospective review of only 13 patients from one hospital, so the numbers are too small to draw firm conclusions.",
      "directness": "indirect",
      "limitations": "Very small sample, retrospective design, single institution, and the fistulas studied are a specific type (rectourethral) caused by prostate surgery rather than typical anal fistulas.",
      "followUp": "59 months",
      "plainFinding": "Some fistulas healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/20018317/",
      "sourceText": "PURPOSE: Rectourethral fistula is a rare but severe complication after radical prostatectomy and there is no standardized treatment. We retrospectively evaluated the incidence, symptoms and management of rectourethral fistulas based on our experience. MATERIALS AND METHODS: From 1999 to 2008 we performed 2,447 radical prostatectomies. Patients in whom postoperative rectourethral fistulas developed were identified. Based on the therapeutic approach patients were categorized into group 1-conservative treatment, group 2-colostomy with or without surgical closure and group 3-immediate surgical closure without colostomy. RESULTS: Rectourethral fistulas developed in 13 of 2,447 patients (0.53%) after radical prostatectomy. The risk of rectourethral fistulas was 3.06-fold higher (p = 0.074) for perineal (7 of 675, 1.04%) than for retropubic prostatectomy (6 of 1,772, 0.34%). In 7 of 13 patients (54%) a rectal lesion was primarily closed at radical prostatectomy. Median followup was 59 months. In all patients in group 1 (3) the fistula closed spontaneously with conservative treatment. None of these patients had fecaluria. In group 2 of the 9 patients 3 (33%) experienced spontaneous fistula closure after temporary colostomy and transurethral catheterization. In this group 6 patients (67%) required additional surgical fistula closure, which was successful in all. Surgical fistula closure (1) without colostomy in presence of fecaluria failed (group 3). CONCLUSIONS: The therapeutic concept for rectourethral fistulas should be guided by clinical symptoms. Rectal injury during radical prostatectomy is a major risk factor. In cases with fecaluria colostomy is required for control of infection and may allow spontaneous fistula closure in approximately a third of cases. In the remainder of cases surgical fistula closure was successful in all after protective colostomy.",
      "provenance": [
        {
          "field": "n",
          "quote": "Rectourethral fistulas developed in 13 of 2,447 patients (0.53%) after radical prostatectomy."
        },
        {
          "field": "population",
          "quote": "Patients in whom postoperative rectourethral fistulas developed were identified."
        },
        {
          "field": "intervention",
          "quote": "group 1-conservative treatment"
        },
        {
          "field": "comparator",
          "quote": "group 2-colostomy with or without surgical closure and group 3-immediate surgical closure without colostomy"
        },
        {
          "field": "primaryOutcome",
          "quote": "the fistula closed spontaneously with conservative treatment"
        },
        {
          "field": "result",
          "quote": "In all patients in group 1 (3) the fistula closed spontaneously with conservative treatment. None of these patients had fecaluria. In group 2 of the 9 patients 3 (33%) experienced spontaneous fistula closure after temporary colostomy and transurethral catheterization. In this group 6 patients (67%) required additional surgical fistula closure, which was successful in all. Surgical fistula closure (1) without colostomy in presence of fecaluria failed (group 3)."
        },
        {
          "field": "followUp",
          "quote": "Median followup was 59 months."
        }
      ]
    },
    {
      "id": "pmid:19897976",
      "pmid": "19897976",
      "doi": "10.1159/000233299",
      "nctId": null,
      "pmcid": null,
      "title": "Treatment algorithms in the case of perianal complications of Crohn's disease",
      "firstAuthor": "Lozynskyy",
      "multipleAuthors": false,
      "journal": "Dig Dis",
      "year": 2009,
      "design": "case-series",
      "n": 52,
      "nField": "reported",
      "population": "patients with Crohn's disease who had perianal fistula",
      "intervention": "surgical treatment of perianal fistula",
      "comparator": "conservative (non-surgical) treatment, as used for fissures in the same cohort",
      "primaryOutcome": "whether the fistula healed or needed surgery",
      "result": "51 of 52 patients with fistulas were operated on; the abstract does not report healing without surgery for fistula patients",
      "resultDirection": "unclear",
      "quality": "very-low",
      "qualityWhy": "This is a retrospective case series without a comparison group, so it cannot show whether fistulas heal without surgery.",
      "directness": "indirect",
      "limitations": "No control group, no statistical comparison, and the population is specifically Crohn's disease patients rather than general anal fistula patients.",
      "followUp": "",
      "plainFinding": "Almost all fistulas were operated on.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/19897976/",
      "sourceText": "AIM: To construct an algorithm of the treatment tactics which would include modern conservative and surgical methods. MATERIALS AND METHODS: Endoscopy under anesthesia, endorectal ultrasonography, histological and radiological examinations, MRT. In the last 22 years, 310 patients with Crohn's disease (CD) have been treated in our clinic of which 144 had perianal complications (60 fissure, 52 fistula, 61 perianal abscess). RESULTS: The treatment of perianal abscesses is opening and drainage, followed by conservative treatment (local and systemic). Using conservative treatment for patients with fissure, clinical remission was attained in 45 (75%); another 15 patients (25%) were operated using Maslyak's method. We have not conducted surgical treatment of fissures for the last 5 years. 51 patients with fistulas were operated on. When the malignization was confirmed, we conducted extirpation of the rectum or coloproctectomy. Recurrence of CD was observed in 65 patients (45.1%) during the first 2 years after the beginning treatment and in 128 patients (88.9%) during 5 years. CDAI varied from 150 to 450. PCDAI was in the range of 5-20. CONCLUSIONS: (1) Planned surgical treatment of perianal complications requires complex examination of the gastrointestinal tract; (2) pararectal fistulas should be operated in the period of complete remission; (3) surgical treatment of perianal complications should be microinvasive, using non-cutting seton, fistulotomy and advancement flap, and (4) coloproctectomy is the final stage of treatment of perianal CD in severe cases.",
      "provenance": [
        {
          "field": "n",
          "quote": "144 had perianal complications (60 fissure, 52 fistula, 61 perianal abscess)"
        },
        {
          "field": "population",
          "quote": "310 patients with Crohn's disease (CD) have been treated in our clinic of which 144 had perianal complications (60 fissure, 52 fistula, 61 perianal abscess)"
        },
        {
          "field": "intervention",
          "quote": "51 patients with fistulas were operated on"
        },
        {
          "field": "comparator",
          "quote": "Using conservative treatment for patients with fissure, clinical remission was attained in 45 (75%)"
        },
        {
          "field": "result",
          "quote": "51 patients with fistulas were operated on"
        },
        {
          "field": "primaryOutcome",
          "quote": "51 patients with fistulas were operated on"
        }
      ]
    },
    {
      "id": "pmid:19210300",
      "pmid": "19210300",
      "doi": "10.1111/j.1463-1318.2009.01811.x",
      "nctId": null,
      "pmcid": null,
      "title": "Seton drainage and fibrin glue injection for complex anal fistulas",
      "firstAuthor": "de Parades",
      "multipleAuthors": true,
      "journal": "Colorectal Dis",
      "year": 2010,
      "design": "case-series",
      "n": 30,
      "nField": "reported",
      "population": "adults with complex anal fistula",
      "intervention": "seton drainage for 8 weeks followed by fibrin glue injection",
      "comparator": "none (single-arm, with comparison of regional vs general anaesthesia subgroups)",
      "primaryOutcome": "complete fistula closure without seepage or abscess",
      "result": "50% of patients were cured at end of follow-up; success was higher with regional anaesthesia than general anaesthesia (68.4% vs 18.2%)",
      "resultDirection": "mixed",
      "quality": "low",
      "qualityWhy": "This was a small, single-group study without a comparison treatment, so it can't prove surgery is avoidable, only that some patients healed with this non-surgical approach.",
      "directness": "direct",
      "limitations": "No control group, small sample size, and some patients had delayed abscess after initial healing.",
      "followUp": "11.7 months (range, 0.2-33.5 months)",
      "plainFinding": "Half healed without full surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/19210300/",
      "sourceText": "OBJECTIVE: The study aimed to evaluate the efficacy of fibrin glue in the treatment of complex anal fistula. METHOD: Thirty consecutive patients with a complex anal fistula underwent glue instillation after an 8 week period of seton drainage. Cure was defined as complete closure of any secondary opening, absence of fistula seepage, and no abscess formation. RESULTS: The mean age of the patients (15 males) was 40.5 (range, 22.8-69.1) years. The mean duration of follow-up was 11.7 (range, 0.2-33.5) months. Complete closure of the fistula was achieved in 17 patients at 1 month but in two patients a delayed abscess occurred. At the end of follow-up, 15 (50%) patients were considered to have been cured. The success rate was no different in cases of Crohn's disease or when postoperative antibiotic therapy was given. There was, however, a significant difference in success following regional vs general anaesthesia (68.4 vs 18.2% success, P = 0.02). CONCLUSION: Fibrin glue cured 50% of our first 30 patients, and regional anaesthesia was predictive of success.",
      "provenance": [
        {
          "field": "n",
          "quote": "Thirty consecutive patients with a complex anal fistula underwent glue instillation"
        },
        {
          "field": "population",
          "quote": "Thirty consecutive patients with a complex anal fistula underwent glue instillation after an 8 week period of seton drainage."
        },
        {
          "field": "intervention",
          "quote": "Thirty consecutive patients with a complex anal fistula underwent glue instillation after an 8 week period of seton drainage."
        },
        {
          "field": "comparator",
          "quote": "There was, however, a significant difference in success following regional vs general anaesthesia (68.4 vs 18.2% success, P = 0.02)."
        },
        {
          "field": "primaryOutcome",
          "quote": "Cure was defined as complete closure of any secondary opening, absence of fistula seepage, and no abscess formation."
        },
        {
          "field": "result",
          "quote": "At the end of follow-up, 15 (50%) patients were considered to have been cured."
        },
        {
          "field": "result",
          "quote": "There was, however, a significant difference in success following regional vs general anaesthesia (68.4 vs 18.2% success, P = 0.02)."
        },
        {
          "field": "followUp",
          "quote": "The mean duration of follow-up was 11.7 (range, 0.2-33.5) months."
        }
      ]
    },
    {
      "id": "pmid:19143149",
      "pmid": "19143149",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "[Cryptoglandular anal fistulas]",
      "firstAuthor": "de Parades",
      "multipleAuthors": true,
      "journal": "Rev Prat",
      "year": 2008,
      "design": "narrative-review",
      "n": null,
      "nField": "not-reported",
      "population": "adults with anal fistulas caused by infected anal glands",
      "intervention": "surgical treatment of the fistula (fistulotomy, sphincter-sparing flap, fibrin glue)",
      "comparator": "antibiotic therapy alone",
      "primaryOutcome": "cure of the fistula (drying up discharge, avoiding recurrence) while preserving continence",
      "result": "surgical fistulotomy is very effective at curing the fistula but carries some risk of anal incontinence; antibiotics are not useful except in special cases",
      "resultDirection": "unclear",
      "quality": "very-low",
      "qualityWhy": "This is a narrative overview of treatment approaches with no study data, comparison groups, or outcome numbers reported.",
      "directness": "indirect",
      "limitations": "No patient numbers, no study design, no comparative data given; it is a general description of management rather than a trial testing whether surgery can be avoided.",
      "followUp": "",
      "plainFinding": "Surgery needed; antibiotics don't work.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/19143149/",
      "sourceText": "Cryptoglandular anal fistulae are the most frequently occurring form of perianal sepsis. Characteristically they have an endoanal primary opening, a fistula track and an abscess and/or an external purulent opening. Antibiotic therapy is not of use in initial management except in special cases. Treatment of an abscess, if present, is required urgently and when possible, consists of its incision under local anaesthesia. Treating the fistula track occurs afterwards and aims to dry up the purulent discharge and avoid recurrence of the abscess by means of surgical fistulotomy. These techniques are very effective in terms of eradication of the problem but there is sometimes a risk of anal incontinence. This explains the increasing interest in sphincter preserving techniques using the advancement of a covering flap of rectal mucosa and the injection of fibrin glue.",
      "provenance": [
        {
          "field": "population",
          "quote": "Cryptoglandular anal fistulae are the most frequently occurring form of perianal sepsis."
        },
        {
          "field": "intervention",
          "quote": "surgical fistulotomy"
        },
        {
          "field": "intervention",
          "quote": "sphincter preserving techniques using the advancement of a covering flap of rectal mucosa and the injection of fibrin glue"
        },
        {
          "field": "comparator",
          "quote": "Antibiotic therapy is not of use in initial management except in special cases."
        },
        {
          "field": "primaryOutcome",
          "quote": "aims to dry up the purulent discharge and avoid recurrence of the abscess"
        },
        {
          "field": "result",
          "quote": "These techniques are very effective in terms of eradication of the problem but there is sometimes a risk of anal incontinence."
        }
      ]
    },
    {
      "id": "pmid:18483799",
      "pmid": "18483799",
      "doi": "10.1007/s00120-008-1765-7",
      "nctId": null,
      "pmcid": null,
      "title": "[Urethral fistula due to Crohn's disease: case report of successful conservative management]",
      "firstAuthor": "Schwab",
      "multipleAuthors": true,
      "journal": "Urologe A",
      "year": 2008,
      "design": "case-series",
      "n": 1,
      "nField": "reported",
      "population": "a patient with a recto-urethral fistula caused by Crohn's disease",
      "intervention": "suprapubic cystostomy plus antibiotics (ciprofloxacin, metronidazole) and immunosuppressive drug (azathioprine)",
      "comparator": "none",
      "primaryOutcome": "complete healing of the fistula",
      "result": "complete remission achieved without surgery",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "This is a single patient case report, so it cannot show whether this result would happen in others.",
      "directness": "indirect",
      "limitations": "Only one patient reported; this fistula was due to Crohn's disease and involved the urethra, not a typical anal fistula.",
      "followUp": "",
      "plainFinding": "Fistula healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/18483799/",
      "sourceText": "We report a case of a recto-urethral fistula in Crohn's disease. In our case, suprapubic cystostomy, ciprofloxacin, metronidazole, and azathioprine led to complete remission. Recto-urethral fistulas due to Crohn's disease are very uncommon. Pneumaturia, faecaluria, urinary tract infection, dysuria, and urethral discharge are the most common complaints. After complete diagnostics, immunosuppressive therapy in complicated Crohn's disease is of increasing importance. It is recommended to continue treatment after healing to prevent further complications.",
      "provenance": [
        {
          "field": "population",
          "quote": "a case of a recto-urethral fistula in Crohn's disease"
        },
        {
          "field": "intervention",
          "quote": "suprapubic cystostomy, ciprofloxacin, metronidazole, and azathioprine"
        },
        {
          "field": "comparator",
          "quote": "led to complete remission"
        },
        {
          "field": "primaryOutcome",
          "quote": "led to complete remission"
        },
        {
          "field": "result",
          "quote": "led to complete remission"
        },
        {
          "field": "n",
          "quote": "We report a case of a recto-urethral fistula in Crohn's disease."
        }
      ]
    },
    {
      "id": "pmid:18371140",
      "pmid": "18371140",
      "doi": "10.1111/j.1572-0241.2007.01741.x",
      "nctId": null,
      "pmcid": null,
      "title": "NOD2/CARD15 gene variants are linked to failure of antibiotic treatment in perianal fistulating Crohn's disease",
      "firstAuthor": "Angelberger",
      "multipleAuthors": true,
      "journal": "Am J Gastroenterol",
      "year": 2008,
      "design": "prospective-cohort",
      "n": 52,
      "nField": "reported",
      "population": "adults with draining perianal fistulas caused by Crohn's disease",
      "intervention": "antibiotic therapy (ciprofloxacin or metronidazole)",
      "comparator": "patients with NOD2/CARD15 wild-type gene versus those carrying NOD2/CARD15 variants",
      "primaryOutcome": "complete closure of the fistula (no drainage even with gentle pressure)",
      "result": "13 of 39 patients with the normal gene had complete fistula closure (33.3%), compared with none of the patients carrying the gene variant (0%)",
      "resultDirection": "mixed",
      "quality": "low",
      "qualityWhy": "this was a small, non-randomized study with no surgical comparison group, so it can only hint at how genetics affect antibiotic response, not prove antibiotics alone cure fistulas.",
      "directness": "indirect",
      "limitations": "Small sample size, no control group without antibiotics, specific to Crohn's-related fistulas rather than general anal fistulas, and genotyping subgroup results involved very few variant carriers.",
      "followUp": "",
      "plainFinding": "Antibiotics healed some fistulas, not others.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/18371140/",
      "sourceText": "OBJECTIVES: The Crohn's disease (CD) susceptibility gene, nucleotide-binding oligomerizetion domain 2 (NOD2)/caspase recruitment domain 15 (CARD15), is linked to the innate immune response associated with altered epithelial bacterial defense. Its relevance in antibiotic therapy of perianal fistulating CD remains elusive. The aim of the study was to explore systematically the association between NOD2/CARD15 variants and clinical response of perianal fistulas in patients using antibiotic therapy. METHODS: Fifty-two patients (median age 36 yr) with draining perianal fistulas were treated with ciprofloxacin (N = 49) or metronidazole (N = 3) for a median duration of 7 wk. Complete response was defined as the absence of any draining fistula despite gentle finger compression. Genotyping for NOD2/CARD15 variants and human beta (beta)-defensin 2 (HBD-2) copies was performed by 5' nuclease assays (Applied Biosystems, Foster City, CA). The examiners and laboratory investigators were blinded. The Fisher exact test and Wilcoxon signed rank test were used for statistical analysis. RESULTS: Ciprofloxacin was discontinued in one patient due to diarrhea after 2 wk. Complete fistula response was observed in 13 of 39 patients with NOD2/CARD15 wild-type (33.3%) compared with none in patients carrying NOD2/CARD15 variants (0%, P= 0.02). The median number of HBD-2 gene copies between responders and partial/nonresponders was similar. CONCLUSIONS: The study result suggests a substantial contribution of NOD2/CARD15 to the antibiotic treatment outcome of perianal fistulating CD. NOD2/CARD15 variants may predispose to an altered intestinal microflora in perianal fistulas that is less responsive to antibiotic treatment.",
      "provenance": [
        {
          "field": "population",
          "quote": "Fifty-two patients (median age 36 yr) with draining perianal fistulas"
        },
        {
          "field": "intervention",
          "quote": "treated with ciprofloxacin (N = 49) or metronidazole (N = 3) for a median duration of 7 wk"
        },
        {
          "field": "comparator",
          "quote": "NOD2/CARD15 wild-type (33.3%) compared with none in patients carrying NOD2/CARD15 variants (0%"
        },
        {
          "field": "primaryOutcome",
          "quote": "Complete response was defined as the absence of any draining fistula despite gentle finger compression"
        },
        {
          "field": "result",
          "quote": "Complete fistula response was observed in 13 of 39 patients with NOD2/CARD15 wild-type (33.3%) compared with none in patients carrying NOD2/CARD15 variants (0%, P= 0.02)"
        },
        {
          "field": "n",
          "quote": "Fifty-two patients (median age 36 yr)"
        }
      ]
    },
    {
      "id": "pmid:17159744",
      "pmid": "17159744",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "[Anastomotic fistulas after colorectal resection for carcinoma: incidence and treatment in our recent experience]",
      "firstAuthor": "Basilico",
      "multipleAuthors": true,
      "journal": "Minerva Chir",
      "year": 2006,
      "design": "retrospective",
      "n": 373,
      "nField": "reported",
      "population": "patients with colorectal cancer who had bowel resection with anastomosis",
      "intervention": "conservative (non-surgical) treatment of anastomotic leak",
      "comparator": "reoperation for the leak",
      "primaryOutcome": "whether the anastomotic fistula closed",
      "result": "9 of 25 fistulas (36%) closed with conservative treatment, while 16 (64%) required reoperation",
      "resultDirection": "mixed",
      "quality": "low",
      "qualityWhy": "This is a single-center retrospective review of surgical complications, not a study of anal fistula disease or a controlled comparison.",
      "directness": "indirect",
      "limitations": "Retrospective, single institution, no control group, and this concerns anastomotic leaks after cancer surgery rather than cryptoglandular anal fistula.",
      "followUp": "",
      "plainFinding": "Some surgical leaks healed without reoperation",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/17159744/",
      "sourceText": "AIM: The incidence of anastomotic fistula after colorectal surgery did not significantly change in the literature during the last years, despite the advances in the treatment with the use of surgical staplers. Taking into account this and other considerations, the authors present their recent experience in the surgical treatment of colorectal carcinoma, referring in particular to anastomotic fistula, related postoperative mortality and results of consequent reoperations. METHODS: From January 1, 2002 to December 31, 2005, 448 patients affected with colorectal cancer were operated on at the Surgical Department of Valduce Hospital in Como, and in 373 cases an anastomosis was performed, subdivided as follows: 144 ileocolic (38.6%), 10 ileorectal (2.7%), 219 colocolic or colorectal (58.7%). RESULTS: Twenty-five out of 373 anastomotic leaks developed (6.7%). In 9 cases (36%), the fistulas spontaneously closed with conservative treatment, while in 16 (64%) reoperation was necessary. With reference to the anatomical site, the leak occurred in 9 out of 144 patients submitted to right hemicolectomy (6.3%), in 14 out of 219 patients after left hemicolectomy or anterior resection of the rectum (6.4%) and in 2 out of 10 patients (20%) after total colectomy. The following is a detailed report of the therapeutic choices adopted by the authors. Four out of 16 reoperated patients (25%) died postoperatively from infective complications related to the fistula, while the total postoperative mortality was 2.2% (10/448). Therefore, anastomotic dehiscence was responsible for 40% of all postoperative deaths. CONCLUSIONS: Among all the different operative choices, the authors give their preference to the direct suture of the fistula and loop ileostomy, which they consider the best available choice. The subsequent operation of ileostomy closure is easier for the surgeon to perform and for the patient to withstand than colostomy closure, particularly after Hartmann's operation.",
      "provenance": [
        {
          "field": "population",
          "quote": "448 patients affected with colorectal cancer were operated on"
        },
        {
          "field": "n",
          "quote": "in 373 cases an anastomosis was performed"
        },
        {
          "field": "intervention",
          "quote": "the fistulas spontaneously closed with conservative treatment"
        },
        {
          "field": "comparator",
          "quote": "in 16 (64%) reoperation was necessary"
        },
        {
          "field": "primaryOutcome",
          "quote": "Twenty-five out of 373 anastomotic leaks developed (6.7%)"
        },
        {
          "field": "result",
          "quote": "In 9 cases (36%), the fistulas spontaneously closed with conservative treatment, while in 16 (64%) reoperation was necessary."
        }
      ]
    },
    {
      "id": "pmid:10873039",
      "pmid": "10873039",
      "doi": "10.1053/jpsu.2000.6931",
      "nctId": null,
      "pmcid": null,
      "title": "The nonoperative management of fistula-in-ano",
      "firstAuthor": "Rosen",
      "multipleAuthors": true,
      "journal": "J Pediatr Surg",
      "year": 2000,
      "design": "case-series",
      "n": 18,
      "nField": "reported",
      "population": "male infants with perianal abscess or fistula",
      "intervention": "watchful waiting without surgery (drainage only if very uncomfortable or febrile)",
      "comparator": "none (no comparison group; historical standard is fistulotomy)",
      "primaryOutcome": "whether the fistula healed without operation",
      "result": "all 14 fistulas healed without surgery over a mean of 6 months",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "small, uncontrolled case series in infants without a comparison group, so it cannot prove surgery is unnecessary in general.",
      "directness": "indirect",
      "limitations": "No control group, small sample, and population limited to male infants, not adults or older children.",
      "followUp": "37 months",
      "plainFinding": "Fistulas healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/10873039/",
      "sourceText": "BACKGROUND/PURPOSE: Fistulotomy is the accepted treatment for infants with perianal fistula. Although recurrence rates range from 0% to 68%. Based on the experience of a senior colleague who noted that babies suffering from perianal fistula follow a self-limited course the authors decided to determine if this observation was accurate. METHODS: A conservative approach to perianal abscess and fistula was used prospectively in 18 male infants. Abscesses were to be drained only if the baby was very uncomfortable or febrile. Once a fistula developed the authors continued observation until the fistula healed. Data are expressed as mean +/- SD. Mean follow-up period was 37 months. RESULTS: Mean age at onset of symptoms was 4 +/- 3 months. Fistulas developed in 14 patients (77%). All fistulas healed without operation. Four patients had abscesses drained for discomfort (n = 3) or fever (n = 1). No patient required antibiotics. Mean duration of symptoms was 6 +/- 4 months. Four patients in whom fistulas did not form healed after incision (n = 3) or spontaneous drainage (n = 1). All patients currently are asymptomatic. CONCLUSIONS: In healthy neonates, perianal abscess and fistula are self-limited conditions rarely requiring surgical drainage and not requiring antibiotics. The conservative management of perianal abscess and fistula in healthy infants appears to be safe and effective.",
      "provenance": [
        {
          "field": "n",
          "quote": "A conservative approach to perianal abscess and fistula was used prospectively in 18 male infants."
        },
        {
          "field": "population",
          "quote": "infants with perianal fistula"
        },
        {
          "field": "intervention",
          "quote": "Abscesses were to be drained only if the baby was very uncomfortable or febrile. Once a fistula developed the authors continued observation until the fistula healed."
        },
        {
          "field": "comparator",
          "quote": "Fistulotomy is the accepted treatment for infants with perianal fistula."
        },
        {
          "field": "primaryOutcome",
          "quote": "Once a fistula developed the authors continued observation until the fistula healed."
        },
        {
          "field": "result",
          "quote": "All fistulas healed without operation."
        },
        {
          "field": "followUp",
          "quote": "Mean follow-up period was 37 months."
        }
      ]
    },
    {
      "id": "pmid:10544475",
      "pmid": "10544475",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "[Conservative therapy of fistulas of the anorectal area in Crohn disease]",
      "firstAuthor": "Peitz",
      "multipleAuthors": true,
      "journal": "Zentralbl Chir",
      "year": 1999,
      "design": "narrative-review",
      "n": null,
      "nField": "not-reported",
      "population": "patients with anorectal fistulas caused by Crohn's disease",
      "intervention": "conservative drug therapy (metronidazole, azathioprine, cyclosporine)",
      "comparator": "surgical treatment",
      "primaryOutcome": "achieving remission of fistula disease before or after surgery",
      "result": "Abstract describes treatment strategy rather than a measured outcome; drug therapy is used alongside surgical consultation and to maintain remission after surgery, not as a stand-alone cure.",
      "resultDirection": "unclear",
      "quality": "very-low",
      "qualityWhy": "This is a descriptive narrative review with no patient numbers or measured outcomes, so it cannot show whether fistulas actually healed.",
      "directness": "indirect",
      "limitations": "No data, sample size, or outcome measures are given; it only describes treatment selection principles.",
      "followUp": "",
      "plainFinding": "Drugs support surgery, don't replace it.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/10544475/",
      "sourceText": "The conservative treatment of ano-rectal fistulae in Crohn's disease is selected according to the clinical activity and chronicity of the underlying disease. While in the acute phase metronidazole is indicated in addition to the standard therapy, an immuno-suppressive treatment with azathrioprine is recommended for the chronic-active course. The long latency of the therapeutic response can be bridged by an intravenous therapy with either cyclosporine ot with high-dose azathropine. The treatment is initiated only after consultation with the surgeon. For the prophylaxis of a post-surgical recurrence, only salicylates are established. Further inter-discipline therapy intended to induce a pre-surgical remission or to maintain a post-surgical remission.",
      "provenance": [
        {
          "field": "population",
          "quote": "The conservative treatment of ano-rectal fistulae in Crohn's disease"
        },
        {
          "field": "intervention",
          "quote": "metronidazole is indicated in addition to the standard therapy, an immuno-suppressive treatment with azathrioprine is recommended for the chronic-active course"
        },
        {
          "field": "intervention",
          "quote": "intravenous therapy with either cyclosporine ot with high-dose azathropine"
        },
        {
          "field": "comparator",
          "quote": "The treatment is initiated only after consultation with the surgeon."
        },
        {
          "field": "primaryOutcome",
          "quote": "intended to induce a pre-surgical remission or to maintain a post-surgical remission"
        },
        {
          "field": "result",
          "quote": "For the prophylaxis of a post-surgical recurrence, only salicylates are established."
        }
      ]
    },
    {
      "id": "pmid:9655272",
      "pmid": "9655272",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "Laser ablation of complex perianal fistulas preserves continence and is a rectum-sparing alternative in Crohn's disease patients",
      "firstAuthor": "Bodzin",
      "multipleAuthors": false,
      "journal": "Am Surg",
      "year": 1998,
      "design": "case-series",
      "n": 7,
      "nField": "reported",
      "population": "Crohn's disease patients with severe, debilitating complex perianal fistula disease",
      "intervention": "laser ablation of fistula tracts (with seton placement)",
      "comparator": "none (compared historically to diverting ileostomy or proctectomy)",
      "primaryOutcome": "fistula healing, continence preservation, and avoidance of rectal surgery",
      "result": "all patients improved; 4 of 4 followed over a year healed completely, continence preserved in all 7, none needed rectal removal, 1 recurrence",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "this is a very small, uncontrolled case series of only 7 patients from one surgeon, so it can't reliably show the treatment works better than other options.",
      "directness": "direct",
      "limitations": "small sample size, no comparison group, single surgeon/center, some patients still healing at time of report",
      "followUp": "more than 1 year",
      "plainFinding": "Healed fistulas, avoided major surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/9655272/",
      "sourceText": "A 20-year review of the inflammatory bowel disease surgical database of the author was analyzed for Crohn's disease (CD) patients who had a surgical approach to perianal fistula disease (PAD). Of 333 patients with CD operated between July 1977 and February 1997, 51 had procedures for PAD (15.3%), and 7 of these patients had laser ablation of severe, debilitating complex PAD (13.7%). These patients have traditionally been treated by diverting ileostomy or proctectomy with permanent diversion. Others have advocated conservative management with long-term antibiotics, staged operations, and insertion of multiple loose setons to promote drainage. This technique was adapted from the laser procedure now advocated for severe hydradenitis suppurativa. The hand-held CO2 laser was used to unroof all fistulas external to the external sphincter. Fistulas were identified by probing. Infected granulation tissue was removed by laser ablation until normal fat or muscle was revealed. Intersphincteric abscesses were unroofed, and a single seton was placed around the external sphincter for all but submucous fistulas. Patients were usually operated as outpatients with pain control effected with oral and transnasal agents. A laparoscopically performed temporary diverting ileostomy was used in one early patient in the series. Patients were followed, and progress was documented by physical examination and photographs. Quality of life was assessed. All patients improved remarkably from their preoperative state. The 4 patients in the group operated more than 1 year before this review have all demonstrated complete healing. The three more recent patients are in various stages of healing. Continence was preserved in 7 of 7 patients. No patient has required rectal excision. Recurrence thought to be related to associated hydradenitis has occurred in 1 patient. Laser ablation is a valuable technique in the management of patients with severe, debilitating complex PAD complicating CD. It effectively eradicates the septic tracks and pockets while preserving sphincter function. It obviates the need for diversion with or without proctectomy.",
      "provenance": [
        {
          "field": "n",
          "quote": "7 of these patients had laser ablation of severe, debilitating complex PAD (13.7%)"
        },
        {
          "field": "population",
          "quote": "Laser ablation is a valuable technique in the management of patients with severe, debilitating complex PAD complicating CD."
        },
        {
          "field": "intervention",
          "quote": "The hand-held CO2 laser was used to unroof all fistulas external to the external sphincter."
        },
        {
          "field": "comparator",
          "quote": "These patients have traditionally been treated by diverting ileostomy or proctectomy with permanent diversion."
        },
        {
          "field": "primaryOutcome",
          "quote": "Continence was preserved in 7 of 7 patients. No patient has required rectal excision."
        },
        {
          "field": "result",
          "quote": "The 4 patients in the group operated more than 1 year before this review have all demonstrated complete healing. The three more recent patients are in various stages of healing. Continence was preserved in 7 of 7 patients. No patient has required rectal excision."
        }
      ]
    },
    {
      "id": "pmid:9553188",
      "pmid": "9553188",
      "doi": "10.1007/s003830050315",
      "nctId": null,
      "pmcid": null,
      "title": "Conservative management of fistula in ano in infants",
      "firstAuthor": "Watanabe",
      "multipleAuthors": true,
      "journal": "Pediatr Surg Int",
      "year": 1998,
      "design": "case-series",
      "n": 97,
      "nField": "reported",
      "population": "infants and children with anal fistula or perianal abscess",
      "intervention": "conservative management (no surgery, watchful waiting)",
      "comparator": "natural course without fistula surgery",
      "primaryOutcome": "spontaneous recovery/resolution within the first year of life",
      "result": "80% of infants recovered spontaneously within their first year, with only 6 children needing surgery after age 2",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This is a small, non-randomized natural-history study in infants with no comparison group, so it can't fully prove surgery is avoidable.",
      "directness": "direct",
      "limitations": "No control group, observational natural-course analysis, population limited to infants under age 2",
      "followUp": "1st year of life",
      "plainFinding": "Most infants healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/9553188/",
      "sourceText": "We analyzed the natural course of fistula in ano (FIA) and/or perianal abscess (PAA) in 97 children (male: 90, female: 7) and recommend conservative management in infants. Nearly one-half of these children had no recurrent episodes, and 80% of the infants recovered spontaneously within their 1st year of life. A radical operation was required in only 6 children after 2 years of age. Two-thirds of the children with a PAA did not develop fistula. Of the children who developed FIA, 42% had no recurrence. Although the duration of FIA was relatively longer than that of PAA, 55% of the children were cured within 1 year. PAA and/or FIA in infants is likely to be a period-limited disorder that occurs mainly in infancy and spontaneously resolves within 1 year of life. Fistulotomy or fistulectomy should be avoided in infants.",
      "provenance": [
        {
          "field": "n",
          "quote": "97 children (male: 90, female: 7)"
        },
        {
          "field": "population",
          "quote": "fistula in ano (FIA) and/or perianal abscess (PAA) in 97 children"
        },
        {
          "field": "intervention",
          "quote": "recommend conservative management in infants"
        },
        {
          "field": "comparator",
          "quote": "Fistulotomy or fistulectomy should be avoided in infants."
        },
        {
          "field": "primaryOutcome",
          "quote": "80% of the infants recovered spontaneously within their 1st year of life"
        },
        {
          "field": "result",
          "quote": "A radical operation was required in only 6 children after 2 years of age."
        }
      ]
    },
    {
      "id": "pmid:8789744",
      "pmid": "8789744",
      "doi": "10.1016/0301-2115(96)02429-3",
      "nctId": null,
      "pmcid": null,
      "title": "Non-surgical repair of rectovaginal fistulae",
      "firstAuthor": "Shafik",
      "multipleAuthors": false,
      "journal": "Eur J Obstet Gynecol Reprod Biol",
      "year": 1996,
      "design": "case-series",
      "n": 12,
      "nField": "reported",
      "population": "women with recurrent rectovaginal fistulas (abnormal connections between rectum and vagina)",
      "intervention": "electrocauterization of the fistula tract (a heat-based probe treatment)",
      "comparator": "",
      "primaryOutcome": "whether the fistula healed without recurrence",
      "result": "all fistulae healed without recurrence",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "This was a very small study of only 12 patients with no comparison group, so it can't reliably show how well this works compared to other treatments.",
      "directness": "indirect",
      "limitations": "Small sample size, no control group, and the fistulas studied were rectovaginal (between rectum and vagina) rather than anal fistulas.",
      "followUp": "mean follow-up 24 months",
      "plainFinding": "Non-surgical healing achieved with cautery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/8789744/",
      "sourceText": "Twelve women with recurrent rectovaginal fistulae (RVF) were treated by electrocauterization (EC). Ten fistulae were obstetric and two followed car accidents; they were located in the lower (4 patients), mid (6 patients) and upper (2 patients) third of the vagina. Under anesthesia, a cauterization probe was introduced into the fistulous track and an electric current was switched on for 30-60 s at a frequency of 20,000 cycles/s and a power of 30 W. Two patients required two sessions but all fistulae healed without recurrence (mean follow-up 24 months). No complications were encountered.",
      "provenance": [
        {
          "field": "population",
          "quote": "Twelve women with recurrent rectovaginal fistulae (RVF) were treated by electrocauterization (EC)."
        },
        {
          "field": "intervention",
          "quote": "treated by electrocauterization (EC)"
        },
        {
          "field": "n",
          "quote": "Twelve women with recurrent rectovaginal fistulae (RVF)"
        },
        {
          "field": "primaryOutcome",
          "quote": "all fistulae healed without recurrence"
        },
        {
          "field": "result",
          "quote": "all fistulae healed without recurrence (mean follow-up 24 months)"
        },
        {
          "field": "followUp",
          "quote": "mean follow-up 24 months"
        }
      ]
    },
    {
      "id": "pmid:8638376",
      "pmid": "8638376",
      "doi": "10.1016/S0090-4295(99)80503-2",
      "nctId": null,
      "pmcid": null,
      "title": "Conservative management of rectocutaneous fistula following radical perineal prostatectomy",
      "firstAuthor": "Lassen",
      "multipleAuthors": true,
      "journal": "Urology",
      "year": 1996,
      "design": "case-series",
      "n": 3,
      "nField": "reported",
      "population": "men who developed a rectal-to-skin fistula after prostate removal surgery",
      "intervention": "non-surgical care: wound care, antibiotics, bowel rest, IV nutrition, and bladder drainage",
      "comparator": "usual surgical diversion (colostomy)",
      "primaryOutcome": "whether the fistula healed",
      "result": "all three fistulas healed without surgery",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "only 3 patients with no comparison group, so it can't reliably show what usually happens.",
      "directness": "indirect",
      "limitations": "Very small case series (3 patients), no control group, and the fistula type (rectocutaneous after prostate surgery) differs from typical anal fistula.",
      "followUp": "",
      "plainFinding": "Healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/8638376/",
      "sourceText": "Inadvertent rectal injury during radical perineal prostatectomy may sometimes lead to the development of a rectocutaneous fistula. This has traditionally been managed with diverting colostomy until closure of the fistula is assured. We report 3 cases of rectocutaneous fistula following radical perineal prostatectomy, which were managed in a more conservative fashion. This included appropriate wound care, antibiotics, bowel rest, parenteral hyperalimentation, and, in the presence of a concomitant urine leak in 1 case, optimal urinary diversion and bed rest. All fistulas healed without incident.",
      "provenance": [
        {
          "field": "n",
          "quote": "We report 3 cases of rectocutaneous fistula following radical perineal prostatectomy"
        },
        {
          "field": "population",
          "quote": "rectocutaneous fistula following radical perineal prostatectomy"
        },
        {
          "field": "intervention",
          "quote": "appropriate wound care, antibiotics, bowel rest, parenteral hyperalimentation, and, in the presence of a concomitant urine leak in 1 case, optimal urinary diversion and bed rest"
        },
        {
          "field": "comparator",
          "quote": "This has traditionally been managed with diverting colostomy until closure of the fistula is assured"
        },
        {
          "field": "primaryOutcome",
          "quote": "All fistulas healed without incident."
        },
        {
          "field": "result",
          "quote": "All fistulas healed without incident."
        }
      ]
    },
    {
      "id": "pmid:8480725",
      "pmid": "8480725",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "Rapid closure of Crohn's disease fistulas with continuous intravenous cyclosporin A",
      "firstAuthor": "Hanauer",
      "multipleAuthors": true,
      "journal": "Am J Gastroenterol",
      "year": 1993,
      "design": "case-series",
      "n": 5,
      "nField": "reported",
      "population": "people with Crohn's disease who had fistulas that didn't respond to previous surgery or medical treatment",
      "intervention": "continuous intravenous cyclosporin A (then switched to oral)",
      "comparator": "none reported",
      "primaryOutcome": "whether the fistulas stopped draining (closed)",
      "result": "10 of the 12 fistulas completely stopped draining, but several later relapsed",
      "resultDirection": "mixed",
      "quality": "very-low",
      "qualityWhy": "This was a tiny, uncontrolled study of only 5 patients with no comparison group, so it can't reliably show whether the drug—or surgery avoidance—actually works.",
      "directness": "indirect",
      "limitations": "No control group, only 5 patients with 12 fistulas of mixed types (only 3 perianal), relapses were common, and one serious side effect (mycotic aneurysm) occurred.",
      "followUp": "6.2 months",
      "plainFinding": "Fistulas closed but often relapsed.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/8480725/",
      "sourceText": "Fistulas complicating Crohn's disease often are refractory to medical management. Immunosuppressive therapy is sometimes effective but requires several months before efficacy can be determined. We treated five patients with Crohn's disease complicated by chronic draining fistulas unresponsive to previous surgery, steroids, antibiotics, total parenteral nutrition, 6-mercaptopurine, or azathioprine with continuous infusion cyclosporin A (CyA). The five patients had a total of 12 fistulas (five enterovaginal, three perianal, three enterocutaneous, one enterovesical). CyA was administered initially at 4 mg/kg/day for 6-10 days, after which oral dosing was begun at 8 mg/kg/day and adjusted to maintain trough serum levels of 100-200 ng/ml. All fistulas responded to CyA infusion with decreased drainage and with improvement in both perifistular inflammation and patient comfort. Complete resolution of drainage was seen in 10 of the 12 fistulas. Initial response was seen after a mean of 3.6 days (range, 2-5 days) with complete cessation of drainage in the 10 fistulas after a mean of 7.9 days (range, 3-28 days). Therapy was continued for a mean of 6.2 months (range, 1.5-18 months). Relapse was seen in two perianal fistulas (3 wk and 7 months) and in two enterovaginal fistulas (1 and 2 months). Two of these recurrences corresponded to lowered serum levels of CyA. An enterocutaneous fistula also recurred after 2.5 months, associated with a distal stricture that required resection. Side effects were minor except for a mycotic aneurysm in one patient which occurred after 7 months of treatment. Intravenous CyA may prove to be a useful agent in the initial management of refractory Crohn's disease fistulas, although relapse as serum levels are lowered and infectious complications are limiting factors for long-term use as a single agent.",
      "provenance": [
        {
          "field": "n",
          "quote": "We treated five patients with Crohn's disease"
        },
        {
          "field": "population",
          "quote": "five patients with Crohn's disease complicated by chronic draining fistulas unresponsive to previous surgery, steroids, antibiotics, total parenteral nutrition, 6-mercaptopurine, or azathioprine"
        },
        {
          "field": "intervention",
          "quote": "continuous infusion cyclosporin A (CyA)"
        },
        {
          "field": "comparator",
          "quote": "We treated five patients with Crohn's disease complicated by chronic draining fistulas unresponsive to previous surgery, steroids, antibiotics, total parenteral nutrition, 6-mercaptopurine, or azathioprine with continuous infusion cyclosporin A (CyA)"
        },
        {
          "field": "primaryOutcome",
          "quote": "Complete resolution of drainage was seen in 10 of the 12 fistulas."
        },
        {
          "field": "result",
          "quote": "Complete resolution of drainage was seen in 10 of the 12 fistulas."
        },
        {
          "field": "followUp",
          "quote": "Therapy was continued for a mean of 6.2 months (range, 1.5-18 months)."
        }
      ]
    },
    {
      "id": "pmid:2253542",
      "pmid": "2253542",
      "doi": "10.1007/BF01540577",
      "nctId": null,
      "pmcid": null,
      "title": "Closure of refractory perineal Crohn's lesion. Integration of hyperbaric oxygen into case management",
      "firstAuthor": "Nelson",
      "multipleAuthors": true,
      "journal": "Dig Dis Sci",
      "year": 1990,
      "design": "case-series",
      "n": 1,
      "nField": "reported",
      "population": "patient with severe Crohn's disease perineal wound that wouldn't heal after removal of diseased bowel",
      "intervention": "hyperbaric oxygen therapy combined with surgical debridement, reconstruction, and medical management",
      "comparator": "none (single case, prior conventional treatments had failed)",
      "primaryOutcome": "complete healing of the perineal wound",
      "result": "the wound completely and permanently closed with combined treatment",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "this is a single patient case report, so it cannot show whether this treatment works in general.",
      "directness": "indirect",
      "limitations": "only one patient; no comparison group; wound was post-surgical not a typical fistula case.",
      "followUp": "",
      "plainFinding": "Wound healed with combined intensive therapy.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/2253542/",
      "sourceText": "A case is reported in which a comprehensive program of hyperbaric oxygen (HBO), surgical debridement and reconstruction, and continuing medical management resulted in complete and sustained closure of an extensive perineal Crohn's lesion refractory to conventional medical and surgical management. It is emphasized that in this case healing occurred in the setting of previous removal of all diseased intestinal tissue and only with the combined use of all three treatment modalities. HBO may be a useful adjunct in the therapy of large nonhealing perineal lesions post-proctocolectomy in patients who are unresponsive to metronidazole or to immunosuppressant therapy or who experience limiting side effects from continued medical therapy.",
      "provenance": [
        {
          "field": "n",
          "quote": "A case is reported"
        },
        {
          "field": "population",
          "quote": "extensive perineal Crohn's lesion refractory to conventional medical and surgical management"
        },
        {
          "field": "intervention",
          "quote": "a comprehensive program of hyperbaric oxygen (HBO), surgical debridement and reconstruction, and continuing medical management"
        },
        {
          "field": "comparator",
          "quote": "refractory to conventional medical and surgical management"
        },
        {
          "field": "primaryOutcome",
          "quote": "complete and sustained closure of an extensive perineal Crohn's lesion"
        },
        {
          "field": "result",
          "quote": "resulted in complete and sustained closure of an extensive perineal Crohn's lesion refractory to conventional medical and surgical management"
        }
      ]
    },
    {
      "id": "pmid:2775367",
      "pmid": "2775367",
      "doi": "10.1016/0090-4295(89)90039-3",
      "nctId": null,
      "pmcid": null,
      "title": "Nonoperative management of iatrogenic prostatorectal fistula",
      "firstAuthor": "Evins",
      "multipleAuthors": false,
      "journal": "Urology",
      "year": 1989,
      "design": "case-series",
      "n": 1,
      "nField": "reported",
      "population": "a patient with a fistula between the prostate and rectum caused by prior urologic surgery",
      "intervention": "nonoperative management with low residue diet, Foley catheter drainage, and antibiotics",
      "comparator": "previous standard treatment of colostomy and suprapubic cystostomy diversion with surgical closure",
      "primaryOutcome": "whether the fistula closed and healed",
      "result": "the fistula healed successfully without surgery using conservative management",
      "resultDirection": "benefit",
      "quality": "very-low",
      "qualityWhy": "this is a single case report with no comparison group, so it cannot show how often this works.",
      "directness": "indirect",
      "limitations": "only one patient described, and the fistula was caused by prostate surgery rather than being a typical anal fistula",
      "followUp": "",
      "plainFinding": "Fistula healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/2775367/",
      "sourceText": "Iatrogenic prostatorectal fistula is a rarely seen urologic complication of transurethral resection of the prostate and stricture dilatation with sounds. In the past, such cases have been managed with colostomy diversion of the fecal stream and suprapubic cystostomy diversion of the urinary stream and in most cases operative closure of the fistula. This case illustrates that a more conservative nonoperative approach can lead to successful closure of such a fistula in selected cases. The management of the case described here utilizes low residue dietary supplements, Foley catheter drainage, and broad-spectrum antibiotics to allow the fistula to heal.",
      "provenance": [
        {
          "field": "n",
          "quote": "This case illustrates that a more conservative nonoperative approach can lead to successful closure of such a fistula in selected cases."
        },
        {
          "field": "population",
          "quote": "Iatrogenic prostatorectal fistula is a rarely seen urologic complication of transurethral resection of the prostate and stricture dilatation with sounds."
        },
        {
          "field": "intervention",
          "quote": "The management of the case described here utilizes low residue dietary supplements, Foley catheter drainage, and broad-spectrum antibiotics to allow the fistula to heal."
        },
        {
          "field": "comparator",
          "quote": "In the past, such cases have been managed with colostomy diversion of the fecal stream and suprapubic cystostomy diversion of the urinary stream and in most cases operative closure of the fistula."
        },
        {
          "field": "primaryOutcome",
          "quote": "successful closure of such a fistula in selected cases"
        },
        {
          "field": "result",
          "quote": "This case illustrates that a more conservative nonoperative approach can lead to successful closure of such a fistula in selected cases."
        }
      ]
    },
    {
      "id": "pmid:3208042",
      "pmid": "3208042",
      "doi": "10.1002/bjs.1800751114",
      "nctId": null,
      "pmcid": null,
      "title": "A new non-operative approach to fistula in ano",
      "firstAuthor": "Misra",
      "multipleAuthors": true,
      "journal": "Br J Surg",
      "year": 1988,
      "design": "case-series",
      "n": 56,
      "nField": "reported",
      "population": "patients with low anal fistulas and high horseshoe anal fistulas",
      "intervention": "outpatient technique passing a multi-strand stainless steel wire through the fistula tract",
      "comparator": "none reported",
      "primaryOutcome": "fistula recurrence and incontinence of flatus or faeces",
      "result": "recurrence in only 2 of 56 patients, with no cases of temporary or permanent incontinence",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "This is a small case series with no comparison group, so it can't prove the new method works better than other options.",
      "directness": "direct",
      "limitations": "No control group, no reported follow-up duration, single case series.",
      "followUp": "",
      "plainFinding": "Non-surgical wire method healed most fistulas.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/3208042/",
      "sourceText": "The results of a new out-patient approach to fistula in ano are presented. The technique involved passing a multi-strand stainless steel wire through the fistulous tract and has been used in 56 patients with low fistulae as well as high horseshoe anal fistulae. Recurrence was seen in only 2 patients and none of the patients experienced temporary or permanent incontinence of flatus or faeces.",
      "provenance": [
        {
          "field": "n",
          "quote": "has been used in 56 patients with low fistulae as well as high horseshoe anal fistulae"
        },
        {
          "field": "population",
          "quote": "56 patients with low fistulae as well as high horseshoe anal fistulae"
        },
        {
          "field": "intervention",
          "quote": "The technique involved passing a multi-strand stainless steel wire through the fistulous tract"
        },
        {
          "field": "comparator",
          "quote": "The results of a new out-patient approach to fistula in ano are presented."
        },
        {
          "field": "primaryOutcome",
          "quote": "Recurrence was seen in only 2 patients and none of the patients experienced temporary or permanent incontinence of flatus or faeces."
        },
        {
          "field": "result",
          "quote": "Recurrence was seen in only 2 patients and none of the patients experienced temporary or permanent incontinence of flatus or faeces."
        }
      ]
    },
    {
      "id": "pmid:3337953",
      "pmid": "3337953",
      "doi": "10.1002/bjs.1800750120",
      "nctId": null,
      "pmcid": null,
      "title": "Anal fissure in Crohn's disease",
      "firstAuthor": "Sweeney",
      "multipleAuthors": true,
      "journal": "Br J Surg",
      "year": 1988,
      "design": "retrospective",
      "n": 61,
      "nField": "reported",
      "population": "patients with Crohn's disease who had an anal fissure",
      "intervention": "conservative medical treatment of the underlying intestinal disease",
      "comparator": "anal surgery",
      "primaryOutcome": "whether the anal fissure healed",
      "result": "the fissure healed in 42 of 61 patients (69%) with medical treatment, while only 6 required surgery (rectal excision) for unhealed fissure",
      "resultDirection": "benefit",
      "quality": "low",
      "qualityWhy": "this is a retrospective chart review of a single hospital's case notes without a control group, so it can show what happened but not prove treatment caused it",
      "directness": "indirect",
      "limitations": "retrospective case-note review, no control group, outcome tied to treatment of Crohn's disease generally rather than the fissure specifically, and this is anal fissure rather than anal fistula",
      "followUp": "",
      "plainFinding": "Most fissures healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/3337953/",
      "sourceText": "There is little information on the natural history of anal fissure in Crohn's disease. The case notes of all new patients with Crohn's disease attending one hospital between 1977 and 1983 were reviewed: there were 61 patients with this diagnosis and an unhealed anal fissure as the only anal lesion. Of these 61 patients the fissure healed in 42 (69 per cent) during medical treatment of the intestinal disease. Ten patients (16 per cent) developed other anal lesions and in the remaining nine patients the fissure remained unhealed at the time of rectal excision (six) or last out-patient attendance (three). Activity of the fissure did not reflect disease activity elsewhere in 11 cases in whom healing of the fissure occurred despite progressive intestinal disease subsequently requiring resection. This study validates the policy of conservative management of anal fissure in Crohn's disease with anal surgery (required in 9.8 per cent of patients in this series) being reserved for the development of other anal disease.",
      "provenance": [
        {
          "field": "population",
          "quote": "there were 61 patients with this diagnosis and an unhealed anal fissure as the only anal lesion"
        },
        {
          "field": "intervention",
          "quote": "the fissure healed in 42 (69 per cent) during medical treatment of the intestinal disease"
        },
        {
          "field": "comparator",
          "quote": "anal surgery (required in 9.8 per cent of patients in this series) being reserved for the development of other anal disease"
        },
        {
          "field": "primaryOutcome",
          "quote": "Of these 61 patients the fissure healed in 42 (69 per cent) during medical treatment of the intestinal disease"
        },
        {
          "field": "result",
          "quote": "Of these 61 patients the fissure healed in 42 (69 per cent) during medical treatment of the intestinal disease."
        },
        {
          "field": "n",
          "quote": "there were 61 patients with this diagnosis and an unhealed anal fissure as the only anal lesion"
        }
      ]
    },
    {
      "id": "pmid:3671218",
      "pmid": "3671218",
      "doi": "10.1080/00325481.1987.11700059",
      "nctId": null,
      "pmcid": null,
      "title": "Anal fissures and fistulas",
      "firstAuthor": "Goldstein",
      "multipleAuthors": false,
      "journal": "Postgrad Med",
      "year": 1987,
      "design": "narrative-review",
      "n": null,
      "nField": "not-reported",
      "population": "people with anal fissures and anal fistulas",
      "intervention": "conservative management (for fissures) or unroofing/fistulotomy (for fistulas)",
      "comparator": "simple incision drainage versus unroofing; conservative management versus sphincterotomy",
      "primaryOutcome": "healing of fissure or fistula",
      "result": "acute fissures often heal with conservative care; fistulas generally need surgical treatment (unroofing of abscess or fistulotomy), with simple incision noted to foster recurrence",
      "resultDirection": "mixed",
      "quality": "very-low",
      "qualityWhy": "This is a general narrative review/opinion piece with no study data, patient numbers, or outcomes reported.",
      "directness": "direct",
      "limitations": "No original data, patient numbers, methodology, or follow-up reported; appears to be a clinical overview rather than a study.",
      "followUp": "",
      "plainFinding": "Fistulas usually need surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/3671218/",
      "sourceText": "Thorough understanding of the pathophysiology of anal fissures and fistulas is essential for the physician treating these conditions. An acute fissure often heals in a month with conservative management; long-standing disease is relieved by lateral internal sphincterotomy. An acute fistulous abscess must be drained by unroofing the abscess rather than by simple incision, which fosters recurrence. Chronic fistula in ano requires fistulotomy, which can be done with a local anesthetic. Fistulas with multiple external orifices should be treated by a specialist in rectal surgery.",
      "provenance": [
        {
          "field": "population",
          "quote": "Anal fissures and fistulas"
        },
        {
          "field": "intervention",
          "quote": "An acute fissure often heals in a month with conservative management"
        },
        {
          "field": "intervention",
          "quote": "Chronic fistula in ano requires fistulotomy, which can be done with a local anesthetic"
        },
        {
          "field": "comparator",
          "quote": "An acute fistulous abscess must be drained by unroofing the abscess rather than by simple incision, which fosters recurrence"
        },
        {
          "field": "primaryOutcome",
          "quote": "An acute fissure often heals in a month with conservative management"
        },
        {
          "field": "result",
          "quote": "long-standing disease is relieved by lateral internal sphincterotomy"
        },
        {
          "field": "result",
          "quote": "Chronic fistula in ano requires fistulotomy, which can be done with a local anesthetic"
        }
      ]
    },
    {
      "id": "pmid:6888834",
      "pmid": "6888834",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "Perineal Crohn's disease",
      "firstAuthor": "Holland",
      "multipleAuthors": true,
      "journal": "Obstet Gynecol",
      "year": 1983,
      "design": "case-series",
      "n": 6,
      "nField": "reported",
      "population": "women with Crohn's disease and rectovaginal fistulas",
      "intervention": "conservative (non-surgical) management",
      "comparator": "surgical approaches including local repair, proximal diversion, or proctocolectomy",
      "primaryOutcome": "healing of the fistula",
      "result": "",
      "resultDirection": "unclear",
      "quality": "very-low",
      "qualityWhy": "This is a small case series of six patients with no comparison group or reported healing outcomes, so it can't show whether fistulas heal without surgery.",
      "directness": "indirect",
      "limitations": "No quantitative outcomes reported; focuses on Crohn's-related rectovaginal fistulas in women, a specific subgroup, and is a descriptive case series without controlled comparison.",
      "followUp": "",
      "plainFinding": "No healing outcomes reported.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/6888834/",
      "sourceText": "Crohn's disease has frequent perineal manifestations, including rectovaginal fistulas. This association is not widely recognized, especially in the gynecologic literature. Six cases of presumptive or documented Crohn's disease associated with rectovaginal fistulas and a review of the literature are presented. The need for a high degree of suspicion and a gastroenterologic evaluation is emphasized. Conservative management is stressed in view of the poor healing characteristics of perineal tissue in these patients. Alternative surgical approaches, including local repair, proximal diversion, and curative total proctocolectomy/ileostomy, are presented. Local repair is fraught with problems including postoperative breakdown and recurrence, yet proctocolectomy is a radical, but curative, procedure. An understanding of the ramifications of surgical intervention along with thorough patient counseling are required in managing these patients.",
      "provenance": [
        {
          "field": "population",
          "quote": "Six cases of presumptive or documented Crohn's disease associated with rectovaginal fistulas"
        },
        {
          "field": "intervention",
          "quote": "Conservative management is stressed in view of the poor healing characteristics of perineal tissue in these patients."
        },
        {
          "field": "comparator",
          "quote": "Alternative surgical approaches, including local repair, proximal diversion, and curative total proctocolectomy/ileostomy, are presented."
        },
        {
          "field": "primaryOutcome",
          "quote": "Local repair is fraught with problems including postoperative breakdown and recurrence, yet proctocolectomy is a radical, but curative, procedure."
        },
        {
          "field": "n",
          "quote": "Six cases of presumptive or documented Crohn's disease associated with rectovaginal fistulas"
        }
      ]
    },
    {
      "id": "pmid:6939193",
      "pmid": "6939193",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "Outcome following treatment of anal fistulae in Crohn's disease",
      "firstAuthor": "Bergstrand",
      "multipleAuthors": true,
      "journal": "Acta Chir Scand Suppl",
      "year": 1980,
      "design": "case-series",
      "n": 24,
      "nField": "reported",
      "population": "patients with anal fistulas caused by Crohn's disease",
      "intervention": "conservative (non-surgical) treatment or local surgery",
      "comparator": "conservative treatment versus local surgery versus major surgery (abdominoperineal excision)",
      "primaryOutcome": "whether the fistula healed",
      "result": "5 of 7 treated conservatively healed; 10 of 13 treated with local surgery healed; 4 with rectal involvement needed major excision surgery",
      "resultDirection": "mixed",
      "quality": "very-low",
      "qualityWhy": "This is a very small, old case series without randomization or control groups, so it cannot reliably show whether one treatment works better than another.",
      "directness": "indirect",
      "limitations": "Small sample of 24 patients, no randomization, no control group, and population limited to Crohn's disease-related fistulas rather than fistulas in general.",
      "followUp": "",
      "plainFinding": "Some fistulas healed without surgery.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/6939193/",
      "sourceText": "The results of treating 24 patients with anal fistulae and active intestinal Crohn's disease is reported. Four patients had multiple extended, seven high and ten low fistulae and three patients had sinus tracts. Seven patients with only minor discomfort were treated conservatively and five of them healed. Thirteen were treated by local surgery and ten subsequently healed. Four patients with rectal Crohn's disease and multiple fitulous systems were submitted to abdominoperineal excision. These results indicate that in patients without rectal involvement, conservative treatment and local surgery is indicated.",
      "provenance": [
        {
          "field": "n",
          "quote": "The results of treating 24 patients with anal fistulae and active intestinal Crohn's disease is reported."
        },
        {
          "field": "population",
          "quote": "24 patients with anal fistulae and active intestinal Crohn's disease"
        },
        {
          "field": "intervention",
          "quote": "Seven patients with only minor discomfort were treated conservatively and five of them healed."
        },
        {
          "field": "comparator",
          "quote": "Thirteen were treated by local surgery and ten subsequently healed."
        },
        {
          "field": "primaryOutcome",
          "quote": "five of them healed"
        },
        {
          "field": "result",
          "quote": "Seven patients with only minor discomfort were treated conservatively and five of them healed. Thirteen were treated by local surgery and ten subsequently healed."
        }
      ]
    },
    {
      "id": "pmid:505265",
      "pmid": "505265",
      "doi": null,
      "nctId": null,
      "pmcid": null,
      "title": "Anorectal abscess",
      "firstAuthor": "Kovalcik",
      "multipleAuthors": true,
      "journal": "Surg Gynecol Obstet",
      "year": 1979,
      "design": "retrospective",
      "n": 181,
      "nField": "reported",
      "population": "patients admitted with anorectal abscesses",
      "intervention": "prompt incision and drainage surgery",
      "comparator": "nonoperative management",
      "primaryOutcome": "recurrence rate after treatment",
      "result": "delays occurred when nonoperative management was tried, and postoperative recurrence rate was at least 6 per cent",
      "resultDirection": "unclear",
      "quality": "low",
      "qualityWhy": "This is an old retrospective chart review of abscesses, not a controlled study of fistula healing, so it can't show whether fistulas heal without surgery.",
      "directness": "indirect",
      "limitations": "Retrospective review describing abscess (not fistula) patients, with delays attributed partly to attempted nonoperative management, no control group or statistical comparison.",
      "followUp": "",
      "plainFinding": "Surgery urged; nonsurgical care caused delays.",
      "retracted": false,
      "expressionOfConcern": false,
      "hasErratum": false,
      "url": "https://pubmed.ncbi.nlm.nih.gov/505265/",
      "sourceText": "A five year retrospective review of anorectal abscesses included 181 admissions in which all but five were explained by the anal glandular hypothesis of causation. Delays in treatment occurred because of misdiagnosis, attempts at nonoperative management and inhospital procrastination. These abscesses are notorious for the recurrence rate after treatment. One-third of the patients in our series had a history of previous abscess and a postoperative recurrence rate of at least 6 per cent. Associated medical problems, such as diabetes mellitus, inflammatory intestinal disease or carcinoma, should be suspected in these patients. The fact that the majority of the patients in our series were afebrile and had minimal leukocytosis is a possible indication that our index of suspicion should be high in any patient with anorectal pain and that we must rely primarily on local findings. Treatment should be prompt incision and drainage under spinal or general anesthesia. Wide unroofing procedures and overzealous attempts at primary fistulotomy are discouraged as is the use of local anesthesia. Associated procedures, such as hemorrhoidectomy, can be safely performed and may prevent certain postoperative complications.",
      "provenance": [
        {
          "field": "n",
          "quote": "181 admissions"
        },
        {
          "field": "population",
          "quote": "anorectal abscesses"
        },
        {
          "field": "intervention",
          "quote": "Treatment should be prompt incision and drainage under spinal or general anesthesia."
        },
        {
          "field": "comparator",
          "quote": "attempts at nonoperative management"
        },
        {
          "field": "primaryOutcome",
          "quote": "These abscesses are notorious for the recurrence rate after treatment."
        },
        {
          "field": "result",
          "quote": "Delays in treatment occurred because of misdiagnosis, attempts at nonoperative management and inhospital procrastination."
        },
        {
          "field": "result",
          "quote": "a postoperative recurrence rate of at least 6 per cent"
        }
      ]
    }
  ],
  "faqs": [
    {
      "q": "Will my anal fistula heal if I just wait?",
      "a": "Based on the limited evidence available, that's unlikely. A review of anal fistula treatment states these tunnels usually do not close on their own, and waiting can let infection and symptoms continue."
    },
    {
      "q": "Should I stop non-surgical treatment and have surgery instead?",
      "a": "If you're currently relying only on antibiotics or watchful waiting, talk to a colorectal surgeon. The limited evidence available suggests surgery closes fistulas more reliably than non-surgical options, though the quality of that evidence is very low."
    },
    {
      "q": "Is a fistula plug a good alternative to surgery?",
      "a": "A combined analysis of earlier studies found fistula plugs came back more often than fistulas treated with surgery (about 62% versus 47%), though rates of bowel-control problems were similar either way."
    },
    {
      "q": "Can antibiotics alone cure a fistula?",
      "a": "The evidence available suggests antibiotics are not generally effective on their own at curing an anal fistula, except in specific situations your doctor would identify."
    },
    {
      "q": "Why is the evidence about this so weak?",
      "a": "Only two studies were found that directly compare non-surgical and surgical treatment in adults with this type of fistula, neither is a randomized trial, and other smaller studies don't fully agree with them — so confidence in any conclusion is very low."
    }
  ],
  "patientTakeaway": "If you have a persistent anal fistula, surgery is still the treatment with the strongest track record; non-surgical options like antibiotics, chemical treatments, or plugs have far weaker support and, in the few studies available, did not clearly match surgery's results. See a colorectal surgeon to discuss your options rather than relying on waiting it out or antibiotics alone.",
  "methodology": {
    "databases": [
      "PubMed",
      "ClinicalTrials.gov",
      "Crossref"
    ],
    "searchStrings": {
      "pubmed": "(\"Rectal Fistula\"[Mesh] OR \"anal fistula\"[tiab] OR \"fistula-in-ano\"[tiab] OR \"fistula in ano\"[tiab]) AND (\"conservative treatment\"[tiab] OR \"conservative management\"[tiab] OR \"nonoperative\"[tiab] OR \"non-surgical\"[tiab] OR \"without surgery\"[tiab] OR \"medical management\"[tiab] OR \"antibiotic therapy\"[tiab] OR \"watchful waiting\"[tiab]) AND (\"healing\"[tiab] OR \"closure\"[tiab] OR \"recurrence\"[tiab] OR \"outcome\"[tiab])"
    },
    "pubmedQueryTranslation": "(\"Rectal Fistula\"[MeSH Terms] OR \"anal fistula\"[Title/Abstract] OR \"fistula-in-ano\"[Title/Abstract] OR \"fistula-in-ano\"[Title/Abstract]) AND (\"conservative treatment\"[Title/Abstract] OR \"conservative management\"[Title/Abstract] OR \"nonoperative\"[Title/Abstract] OR \"non-surgical\"[Title/Abstract] OR \"without surgery\"[Title/Abstract] OR \"medical management\"[Title/Abstract] OR \"antibiotic therapy\"[Title/Abstract] OR \"watchful waiting\"[Title/Abstract]) AND (\"healing\"[Title/Abstract] OR \"closure\"[Title/Abstract] OR \"recurrence\"[Title/Abstract] OR \"outcome\"[Title/Abstract])",
    "searchedOn": "2026-10-05",
    "inclusion": [
      "Human, animal or laboratory studies reporting an outcome relevant to the question"
    ],
    "exclusion": [
      "Records about a different condition or intervention",
      "Records reporting no outcome",
      "Retracted publications, which are listed but excluded from every count"
    ],
    "extractionLevel": "abstract",
    "gradingNote": "Evidence strength is adapted from the GRADE framework. It is not a GRADE assessment and was not produced by a GRADE panel.",
    "limits": [
      "Fields were read from abstracts, not full text, so detail reported only in a paper's methods section is not captured."
    ]
  },
  "seo": {
    "title": "Can an Anal Fistula Heal Without Surgery?",
    "description": "Only two low-quality studies compare non-surgical care with surgery for anal fistula, and both hint surgery works better."
  },
  "lastChecked": "2026-10-05",
  "lastChanged": "2026-10-05",
  "nextCheckDue": "2026-11-05",
  "history": [],
  "pipeline": {
    "screenModel": "claude-haiku-4-5",
    "extractModel": "claude-sonnet-5",
    "composeModel": "claude-sonnet-5",
    "promptVersion": "ev-1",
    "ranOn": "2026-10-05"
  },
  "status": "published"
}