OTSC® Proctology vs. fistulectomy and primary sphincter reconstruction as a treatment for low trans-sphincteric anal fistula in a randomized controlled pilot trial.

Abstract

The aim of this study was to compare OTSC® proctology and fistulectomy with primary sphincter reconstruction results as treatment strategies for anorectal low trans-sphincteric fistula. Between February 2012 and March 2013, patients affected by trans-sphincteric anal fistula were consecutively enrolled in the trial. Patients were randomized to receive fistulectomy with primary sphincter reconstruction or OTSC® Proctology. Demographic characteristics, comorbodities, previous anorectal treatments, and recurrent fistula data were acquired. Postoperative therapy data and pain and Wexner scores (30 and 60 dd) were acquired during follow-up. Furthermore, patients were contacted by telephone after six months, and were visited both one year and three years after surgery. Thirty consecutive patients were included in the study. 15 patients underwent the OTSC® Proctology procedure and 15 underwent the standard fistulectomy. The success rate was 93.3% in the OTSC group. The mean postoperative stay was 1.3 days in the OTSC® patients and 3.6 days in the fistulectomy group patients. The mean medications required for complete healing was 3.2 in the OTSC group and 8.9 in the FIPS group. Our results suggest that OTSC® Proctology is an effective and safe treatment in achieving permanent closure of the internal fistula opening in selected patients, with excellent results in terms of pain, postoperative incontinence, healing time, and days of hospitalization.