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

BACKGOUND: Effective, 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. METHODS: Retrospective 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. RESULTS: Twenty-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. CONCLUSIONS: This 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 INFORMATION: The online version contains supplementary material available at 10.1007/s10151-022-02593-1.