Dataset Information

Efficacy of Permacol injection for perianal fistulas in a tertiary referral population: poor outcome in patients with complex fistulas.

ABSTRACT:

Aim

Injection of Permacol collagen paste can be used as a sphincter-sparing treatment for perianal fistulas. In a tertiary referral population we aimed to evaluate the efficacy of Permacol injection and the clinical and fistula-related factors associated with recurrence.

Method

This was a retrospective analysis of consecutive patients with perianal fistulas treated with Permacol injection at a specialist centre between June 2015 and April 2019. Endoanal ultrasonography was systematically reanalysed, blinded to treatment outcome. Rectovaginal, anovaginal and Crohn's disease fistulas were excluded. Healed fistulas were defined as absent anal symptoms and a closed external opening on physical examination at a minimum follow-up of 6 months. Regression analyses were performed to identify factors associated with unhealed fistulas.

Results

A total of 90 patients (51 men; median age 45 years) were analysed. Seventy-two (80.0%) patients had complex perianal fistulas (greater than one-third sphincter involvement or multiple tracts). After a single Permacol injection, fistulas were healed in 20 (22.2%) patients at 3 months follow-up and in 18 (20.0%) patients at a median follow-up of 30 months (interquartile range 17-37). Eight (11.1%) patients with unhealed fistulas had significant improvement in their symptoms. Complex fistulas were significantly associated with unhealed status [OR 3.53 (95% CI 1.12-11.09); p = 0.031]. Twenty patients underwent subsequent Permacol injections, which were successful in six (30.0%) patients after one (n = 3) or two (n = 3) additional injections.

Conclusion

This largest study to date in patients with mainly complex perianal fistulas, demonstrated that the efficacy of a single Permacol injection was only 20%. Complex fistulas were associated with a poor outcome.

SUBMITTER: Vollebregt PF

PROVIDER: S-EPMC8453864 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionA high prevalence of cryptoglandular and Crohn's perianal fistulas has been reported worldwide, and several surgical options are available for the management of anal fistula, with varying clinical efficacy. However, currently, the available evidence for the effectiveness of these surgical approaches are lacking and of concern in terms of the credibility and strength. The purpose of this study is to evaluate the credibility of the published systematic reviews and meta-analyses that assess the efficacy and safety of the surgical options for cryptoglandular and Crohn's perianal fistulas through an umbrella review.Methods and analysisA systematic search in PubMed, Embase and Cochrane library will be performed from inception to December 2020 without any language restriction. We will include systematic reviews and meta-analyses that investigate the efficacy and safety of surgical approaches in the management of cryptoglandular and Crohn's perianal fistulas. Two reviewers will independently screen search results through reading the titles or abstracts. Relevant information will be extracted from each eligible systematic review or meta-analysis. Based on random effects model summary estimates along with their p values, 95% prediction intervals, between-study heterogeneity, small-study effects and excess significance, we will classify the evidence from convincing (class I) to weak (class IV). Findings will be summarized using quantitative synthesis combined with a narrative approach. Cryptoglandular and Crohn's perianal fistulas will be summarized separately. Two authors will independently perform the literature search, data extraction, and quality assessment of each included systematic review and meta-analysis. Any unresolved conflicts or doubts will be resolved by discussion or by consulting a senior author. The risk of bias of the systematic reviews will be assessed using a 16-item Assessment of Multiple Systematic Reviews 2 (AMSTAR2) checklist. The strength of evidence for the included systematic reviews will be classified as "high", "moderate", "low", or "critically low" quality.Ethics and disseminationEthics approval is not required as we will collect data from the published systematic reviews and meta-analyses without using individual patient data. The results of this umbrella review will be published in a peer-reviewed journal and will be presented at an anorectal disease conference.Prospero registration numberCRD42020200754.