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©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Feb 27, 2021; 13(2): 187-197
Published online Feb 27, 2021. doi: 10.4240/wjgs.v13.i2.187
Perianal fistulodesis – A pilot study of a novel minimally invasive surgical and medical approach for closure of perianal fistulae
Roxanne Villiger, Daniela Cabalzar-Wondberg, Daniela Zeller, Pascal Frei, Luc Biedermann, Christian Schneider, Michael Scharl, Gerhard Rogler, Matthias Turina, Andreas Rickenbacher, Benjamin Misselwitz
Roxanne Villiger, Pascal Frei, Luc Biedermann, Christian Schneider, Gerhard Rogler, Benjamin Misselwitz, Department of Gastroenterology and Hepatology, University Hospital of Zurich, Zurich 8091, Switzerland
Daniela Cabalzar-Wondberg, Matthias Turina, Andreas Rickenbacher, Visceral- and Transplant Surgery, University Hospital of Zurich, Zurich 8091, Switzerland
Daniela Zeller, Department of Surgery, Zeller Surgery, Zurich 8008, Switzerland
Michael Scharl, Department of Gastroenterology, University Hospital of Zurich, Zurich 8091, Switzerland
Benjamin Misselwitz, Visceral Surgery and Medicine, University Hospital of Bern, Bern 3010, Switzerland
Author contributions: Misselwitz B, Rogler G, Turina M, Zeller D, Frei P, and Schneider C contributed to concept and design of the study; Misselwitz B, Rickenbacher A, Cabalzar-Wondberg D, Zeller D, and Biedermann L contributed to recruitment and clinical care of patients; Misselwitz B, Rickenbacher A, Cabalzar-Wondberg D, Zeller D, Biedermann L, Scharl M, Burk S, and Villiger R contributed to data acquisition; Villiger R and Misselwitz B contributed to statistical analysis; Misselwitz B, Villiger R, Rickenbacher A, and Cabalzar-Wondberg D contributed to interpretation of data; Villiger R, Misselwitz B, Cabalzar-Wondberg D, Rickenbacher A, Rogler G, and Zeller D contributed to drafting of the article and critical revisions to the manuscript; Cabalzar-Wondberg D and Villiger R contributed equally to this work and share the first authorship; Rickenbacher A and Misselwitz B contributed equally to this work and share the last authorship; all authors final approval of version of the article to be published.
Institutional review board statement: The study was reviewed and approved by the kantonalen Ethikkomission Zürich (Approval No. 2019-00208).
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Benjamin Misselwitz, MD, Professor, Clinique for Visceral Surgery and Medicine, Inselspital Bern, University Hospital of Bern, Freiburgstrasse 4, Bern 3010, Switzerland. benjamin.misselwitz@insel.ch
Received: September 1, 2020
Peer-review started: September 1, 2020
First decision: October 23, 2020
Revised: November 20, 2020
Accepted: December 23, 2020
Article in press: December 23, 2020
Published online: February 27, 2021
ARTICLE HIGHLIGHTS
Research background
Perianal fistulae are frequent, yet poorly understood conditions occurring in otherwise healthy individuals, as well as in patients with Crohn’s disease (CD). A wide range of surgical treatment options including fibrin glue instillation exist, nevertheless, healing rates vary largely and are unsatisfying especially in patients with CD. There is an ongoing need to establish safe, economic and well-tolerated but highly effective treatment options for perianal fistulae.
Research motivation
To develop an effective minimally invasive fistula treatment.
Research objectives
To establish safety and effectiveness of fistulodesis, a combined medical-surgical treatment option for perianal fistulae.
Research methods
Non-CD and CD patients with perianal fistula were treated with fistulodesis in an open label uncontrolled study. Patients with complex fistula, > 2 fistula openings and active CD were excluded. Fistulodesis comprises flushing of the fistula tract with acetylcysteine and doxycycline, instillation of fibrin glue into the fistula tract and surgical closure of the internal opening. The primary endpoint of our study was fistula healing, defined as macroscopic and clinical fistula closure and lack of patient reported fistula symptoms at 24 wk.
Research results
Fistulodesis was tested in 17 non-CD and 3 CD patients. Fistula healing was observed in 30% of patients after 24 wk and healed fistulae remained closed for more than one year after treatment. No severe side effects were observed. Low clinical fistula activity with a low perianal disease activity index was associated with fistula healing.
Research conclusions
Fistulodesis is a minimally invasive and safe treatment option for perianal fistulae with limited effectiveness, comparable to other minimally invasive treatment options.
Research perspectives
Effectiveness of fistulodesis in CD patients could be tested in a future dedicated clinical trial. Our stringent composite primary endpoint of fistula healing, could be useful in future clinical studies for fistula treatment.
