The OTSC® Proctology clip system for anal fistula closure: First prospective clinical data

Abstract

Introduction: Anorectal fistulas represent a troublesome condition for both patient and surgeon. The OTSC® Proctology clip system is a new device for transanal anorectal fistula closure. Material and methods: The OTSC® Proctology system was evaluated in a prospective clinical study undertaken in two surgical proctological centers. Ten patients (three women, seven men; median age 55 years, range 25-73 years) with nine transsphincteric and one suprasphincteric fistulas were enrolled into the study. Results: The median operation time was 30 minutes (range 20-45 minutes). There were no intraoperative technical or surgical complications. Postoperatively, no patient reported intolerable discomfort, immoderate pain or foreign body sensation in the anal region. At follow-up examination six months after surgery, nine out of ten patients had no clinical signs or symptoms of their previous fistula and were considered as healed (success rate 90%). In one patient persistency of the fistula was noted due to spontaneous early clip detachment on the third postoperative day. Discussion: These first data demonstrate the efficacy of the OTSC® Proctology system in the treatment of anal fistulas. Currently, more patients were enrolled into this prospective study to allow further evaluation of this new device and to assess its future role in relation to established surgical strategies for anorectal fistulas.

Key words::

• Anal fistula
• OTSC
• proctology
• clip
• Nitinol

Declaration of interest: Ruediger L. Prosst is senior medical consultant of novineon CRO & Consulting Ltd. which advises Ovesco Endoscopy AG in regulatory affairs and product development. The OTSC® Proctology system and its accessories in this clinical study were supplied courtesy of Ovesco Endoscopy AG. The authors did not receive any direct payments or gratifications.