OTSC Proctology, Ovesco Endoscopy AG

OTSC® Proctology: Pilot RCT shows efficacy and safety in achieving permanent closure of cryptoglandular anal fistulas

When compared to fistulectomy and primary sphincter reconstruction, the OTSC Proctology showed comparable results (93 % primary healing rate) but a significantly reduced number of hospitalization days and medications after treatment.

Mascagni D et al., Department of Surgical Sciences, Sapienza University, Rome, Italy, published a randomized controlled trial comparing the OTSC Proctology with standard fistulectomy and primary sphincter reconstruction for the treatment of anorectal low trans-sphincteric fistula. Between 02/2012 and 03/2013, patients affected by trans-sphincteric anal fistula were consecutively enrolled in the trial. Patients were randomized to receive fistulectomy with primary sphincter reconstruction of OTSC Proctology. Demographic characteristics, comorbidities, previous anorectal treatments, and recurrent fistula data were acquired. Post-operative therapy data and Wexner scores (30 and 60 dd) were acquired during follow-up.

30 consecutive patients were included in the study.15 patients underwent the OTSC Proctology procedure and 15 patients underwent standard fistulectomy. The primary healing rate was 93.3 % in the OTSC group, in one patient a relapse fistula developed after 30 days which had to be re-treated surgically. No relapse fistula occurred in the fistulectomy group. The mean postoperative stay was 1.3 days in the OTSC group and 3.6 days in the fistulectomy group. The mean medications required for complete healing was 3.2 (range 2-5) in the OTSC group and 8.9 (range 7-12) in the fistulectomy group. The Wexner Score at 30 days was 0 (range 0-0) in the OTSC group and 3 (range 0-6) in the fistulectomy group. After 60 days, the Wexner score was 0 in both groups. After 6 months, all patients underwent MRI examination, which showed complete healing in all patients. In the 3 years of follow-up, none of the patients showed recurrence of the fistula or incontinence.

The authors concluded that the OTSC Proctology is an effective and safe tool for achieving permanent closure of the internal opening of anal fistulas, with excellent results in terms of pain, postoperative incontinence, healing time, and days of hospitalization.

OTSC® Proctology vs. fistulectomy and primary sphincter reconstruction as a treatment for low trans-sphincteric anal fistula in a randomized controlled pilot trial.
Mascagni D, Pironi D, Grimaldi G, Romani AM, LA Torre G, Eberspacher C, Palma R, Sorrenti S, Pontone S.
Minerva Chir. 2018 Feb 1. doi:10.23736/S0026-4733.18.07617-4. [Epub ahead of print]