The OTSC(®) proctology clip system for the closure of refractory anal fistulas.

BACKGROUND: To evaluate the efficacy of the over-the-scope clip (OTSC(®)) proctology set for the closure of refractory anal fistulas.

METHODS: This retrospective single-center study included all consecutive patients undergoing an OTSC(®) proctology closure of anal fistulas between October 2012 and June 2014. The OTSC(®) was only used in refractory cases after previous fistula surgery, including patients with Crohn's disease, or multiple previous surgical approaches.

RESULTS: There were ten patients (five males and five females) with a median age of 41 years (range 26-69 years). The etiology of the fistula was cryptoglandular in four patients, and perianal Crohn's disease in six patients (including one patient with an anovaginal fistula). The surgical procedure was technically successful in all patients. Permanent fistula closure was achieved in seven out of ten patients (70 %) within a median time of 72 days (range 31-109 days). Median total follow-up time was 230.5 days (range 156-523 days). There were three failures (30 %), including two cryptoglandular and one Crohn's disease-associated fistula. In all three cases, the OTSC(®) was lost spontaneously on days 22, 23, and 40, respectively. In three of the seven patients with successful closure, the OTSC(®) was removed after complete healing of the fistula.

CONCLUSIONS: The novel OTSC(®) proctology system is a safe and effective method for the closure of even complex and recurrent fistulas.