Treatment of Fistula-in-ano With OTSC^® Proctology Clip Device: Short-term Results

Introduction: The treatment of anal fistula with the OTSC^® (over-the-scope-clip) proctology device involves the placement of an elastic alloy clip called Nitinol on the internal fistula opening to achieve fistula healing. The aim of this study was to analyze preliminary results of this technique in a case series.

Methods: This was a retrospective analysis of patients who underwent OTSC^® clip placement for fistula-in-ano treatment between June 2015 and March 2017 at a specialized colorectal unit. Patients with simple and complex fistulae, either previously treated or not, were included in the study. Both cryptoglandular and stable Crohn's disease fistulae were considered for this approach. Technique failure was determined by the re-appearance of anorectal suppuration or in clip-related complications.

Results: Ten patients were treated surgically for anal fistula with a median age of 54 years (range: 41-70years). The etiology of the fistulae was mainly cryptoglandular. Three patients had simple fistulae, whereas seven had complex disease. 80% of the patients had already undergone previous fistula surgery. No events occurred during the procedure. The success rate for healing was 60%, with a median follow-up of 15months (range: 6-26months). Three patients developed suppuration relapse and one patient required clip extraction due to invalidating anal pain. No fecal incontinence was recorded after the procedure.

Conclusions: The treatment of anal fistulae with the OTSC^® device is a safe sphincter-saving technique in the short term.