Anal fistula, with its complicated pathogenesis, has been considered as a clinical challenge for centuries. The risk of frequent recurrence and incontinence constitutes a considerable threat in the long-term treatment of anal fistula. In this work, we narratively reviewed the scientific literature of new techniques that have been used for anal fistula treatment over the recent 5 years, objectively evaluated the pros and cons of each technique on the basis of clinical outcomes, and tried to disclose the effective strategies for anal fistula treatment. Up to date, surgery is the main method used for treating anal fistula, but there is no simple technique that can completely heal complex anal fistula. In the course of surgery treatment, the healing outcome, and the protection of anal function should be weighed comprehensively. Among the innovative techniques that have emerged in recent years, combined techniques based on drainage Seton and LIFT-plug seem to be the relatively effective therapies, but their effectiveness requires more multi-center prospective randomized controlled trials with large sample size and long-term follow-up to be validated.
Background:
Anal fistula is a common anorectal disease. So far, operation is still the optimal method to cure anal fistula. High anal fistula (HAF) is an even more clinically difficult disease to treat. Evidence suggested that seton placement can be a definitive treatment for HAF. However, tightening the seton brings great pain to patients, which affects the clinical application of the therapy. Also, this may lead to difficulty in controlling anal fluids and gas because of the larger scar left and the local defect in the anal after the operation. We propose an innovative seton technique for the treatment of HAF, after long term attempts, the operation of the modified seton cutting technique. The aim of our present study is to compare the difference of anal function, healing time, pain severity, recurrence, and complications between the procedure of the modified seton cutting technique and the conventional cutting seton operation against HAF with a randomized, controlled, prospective study.
Methods:
204 participants in this trial will be randomly divided into treatment group (procedure of the modified seton cutting technique) and control group (cutting seton technique) in a 1:1 ratio. The outcomes of continence state, pain severity after tightening, complete healing of fistula, duration to healing, operation time, recurrence rates, and postoperative complications will be recorded at 1, 2, 3, 4 weeks, then every month in the outpatient clinic. Data will be analyzed by SPSS version 22.
Conclusions:
The findings of the study will help to explore the efficacy and safety of the procedure of the modified seton cutting technique against AF.
Trial registration number:
DOI 10.17605/OSF.IO/V6G2S
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.