Long-term outcomes of an acellular dermal matrix for the treatment of complex cryptoglandular anal fistula: a pilot study.

M J Gómez-Jurado,A Galvez,M Martí-Gallostra,G Pellino,S Biondo,E Espín-Basany,E Kreisler

doi:10.1007/s10151-022-02593-1

Abstract

BackgoundEffective, standardized treatments for complex anal fistula (CAF) still represent a clinical challenge. Emerging procedures attempted to achieve the healing rates of fistulotomy whilst preserving sphincter function. Acellular dermal matrix (ADM) used as a plug inserted through the fistulous tract is among newer treatment options. Varying success rates have been reported, most with short-term follow-up. The aim of this study was to report the long-term results of ADM-plug for CAF.MethodsRetrospective analysis of a prospective database of patients treated with CAF. All consecutive patients presenting at two tertiary centers (Vall d’Hebron University Hospital and Bellvitge University Hospital, Barcelona, Spain) between November 2015 and March 2019 with a single, cryptoglandular CAF were evaluated for treatment with an ADM-plug were included. The primary endpoint was absence of discharge at clinical examination at 12 month follow-up.ResultsTwenty-two patients were included [7 women and 15 men, median age 56 (33–74) years]. Most patients had high transsphincteric fistulas (63.6%). The median follow-up was 42 (21–53) months. The 12 month success rate was 68.2%, with an overall healing rate of 59.1%. 77.8% of recurrences occurred within 12 months from surgery. One plug extrusion was observed. No major complications or mortality occurred during the follow-up. Patients did not report any worsening of fecal continence.ConclusionsThis pilot study showed that more than half of patients with CAF could benefit from ADM-plug placement, preserving continence. A minimum follow-up of 12 months is recommended, because most recurrences occur during the first year.Supplementary InformationThe online version contains supplementary material available at 10.1007/s10151-022-02593-1.

Highlights

Anal fistula treatment depends on fistula anatomy, the cause of the fistula and the amount of involved external anal sphincter muscle [1, 2]
24 consecutive patients with single complex anal fistulas (CAF) were treated with an absorbable porcine Acellular dermal matrix (ADM) pyramidal (110 × × 4.5 mm) plug (PressFit®) and had a minimum of months of follow-up
Most studies published to date are based on a different ADM-plug, described as non-crosslinked, collagen-based extracellular matrix (ECM) material derived from porcine small intestinal submucosa (Fistula Biodesign plug—Cook S urgisis®)

Summary

Introduction

Anal fistula treatment depends on fistula anatomy, the cause of the fistula and the amount of involved external anal sphincter muscle [1, 2]. Surgery for complex anal fistulas (CAF) is associated with higher recurrence rates and higher risk of injury to the anal sphincter complex, resulting in flatus and/or fecal incontinence [3, 4]. The risk of incontinence is higher in women and in anteriorly located fistulas [4,5,6]. Surgery for CAF often involves staged procedures, with seton placement and delayed definitive treatment. Fistulotomy achieves the highest healing rates, but it implies a potential risk of continence worsening or “de novo” incontinence, reported in more than 10% of patients [7]. Advancement flaps represent a viable option for CAF, with success

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