Long-Term Clinical Results of Use of an Anal Fistula Plug for Treatment of Low Trans-Sphincteric Anal Fistulas.

Abstract

BackgroundAn anal fistula plug is a sphincter-sparing procedure that uses biological substances to close an anorectal fistula. This study aimed to evaluate the long-term therapeutic effect of an anal fistula plug procedure in patients with trans-sphincteric fistula-in-ano and to determine the risk factors affecting fistula healing.Material/MethodsA single-center retrospective study was performed assessing long-term treatment outcomes of patients with low trans-sphincteric anal fistulas who initially underwent anal fistula plug procedures between August 2008 and September 2012. Risk factors affecting fistula healing were identified using univariate and multivariate analyses.ResultsA total of 135 patients who had low trans-sphincteric anal fistulas and underwent anal fistula plug procedures were analysed. The overall healing rate was 56% (75/135) with a median follow-up time of 8 years (range, 72–121 months). The primary reasons for treatment failure were plug extrusion (n=12, 20%) and surgical site infection (n=9, 15%), occurring within 30 days after surgery. Multiple logistic regression analysis showed that the duration of anal fistula ≥6 months was significantly associated with treatment failure using an anal fistula plug (OR=3.187, 95% CI: 1.361–7.466, P=0.008). Of the patients who failed initial treatment with an anal fistula plug, 6 (9%) had anal fistulas that healed spontaneously after 2–3 years without additional treatment.ConclusionsAs a sphincter-preserving procedure, the anal fistula plug can effectively promote healing of low trans-sphincteric anal fistulas. The long-term efficacy is good and the procedure warrants wider use in clinical practice.