Prospective Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 14, 2016; 22(30): 6936-6943
Published online Aug 14, 2016. doi: 10.3748/wjg.v22.i30.6936
Prospective evaluation of a new device for the treatment of anal fistulas
Carlo Ratto, Francesco Litta, Lorenza Donisi, Angelo Parello
Carlo Ratto, Francesco Litta, Lorenza Donisi, Angelo Parello, Proctology Unit, Department of Surgical Sciences, Catholic University, 00168 Rome, Italy
Author contributions: Ratto C contributed to conception and design, data collection, analysis of literature; Litta F contributed to design, data collection, analysis of literature, writing of the manuscript; Donisi L and Parello A contributed to design, data collection, analysis of literature.
Conflict-of-interest statement: Authors of this article have no commercial associations that might give rise to a conflict of interest in connection with the article submitted.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Correspondence to: Carlo Ratto, MD, FASCRS, Proctology Unit, Department of Surgical Sciences, Catholic University, Largo A. Gemelli, 8, 00168 Rome, Italy.
Telephone: +39-335-6886968 Fax: +39-06-30156579
Received: March 29, 2016
Peer-review started: April 5, 2016
First decision: May 12, 2016
Revised: June 11, 2016
Accepted: July 6, 2016
Article in press: July 6, 2016
Published online: August 14, 2016

AIM: To evaluate the safety of the implantation of a new device for the treatment of anal fistulas. The short-term clinical efficacy was also assessed.

METHODS: This study took place at a tertiary care university hospital. Patients with a complex anal fistula of cryptoglandular origin were enrolled in the study and were treated with insertion of the new device. All patients were evaluated by clinical and physical examination, including an endoanal ultrasound at the baseline, and then at the 2 wk and 1, 2, 3 and 6-mo follow-up visits.

RESULTS: Morbidity, continence status, and success rate were the main outcome measures. Ten patients underwent the placement of the new device. The fistulas were transphincteric in eight patients and extrasphincteric in the remaining two. The median duration of the surgical procedure was 34.5 (range, 27-42) min. Neither intra- nor postoperative complications occurred, and all patients were discharged the day after the procedure. At the 6-mo follow-up evaluation, the final success rate was 70%. Three failures were registered: a device expulsion (on the 10th postoperative day), the persistence of inflammatory tissue around the fistula tract (at the 2-mo follow up), and the persistence of serum discharge (at the 6-mo follow up). No patient experienced any change incontinence, as assessed by the Cleveland Clinic Fecal Incontinence score.

CONCLUSION: The technical procedure is simple and has low risk of perioperative morbidity. The pre- and post-operative continence status did not change in any of the patients. The initial results at the 6-mo follow up seem to be promising. However, a longer follow-up period and a larger sample size are needed to confirm these preliminary results.

Keywords: Anal fistula, Device, Fistula plug, Faecal incontinence, Recurrence, Endoanal ultrasound

Core tip: Surgical treatment of anal fistulas is still controversial. This prospective study is the first to reporton the implantation of a new device, the Curaseal AF™ device. Several interesting results emerged concerning the safety of the procedure and its effectiveness in the short-term follow-up.