Comparing Two Sphincter-Saving Surgeries for High Anal Fistulas TROPIS Versus Coring Out Fistulectomy

What this Trial Is About

High anal fistulas, which involve more than one-third of the anal sphincter complex, are difficult to treat surgically due to high recurrence rates and the risk of postoperative fecal incontinence. Researchers are comparing two sphincter-preserving techniques the traditional Coring Out fistulectomy and the newer Transanal Opening of the Intersphincteric Space TROPIS method. This randomized clinical trial aims to evaluate the effectiveness, safety, and patient outcomes of these two treatments for managing high complex anal fistulas. Participants will receive either the TROPIS procedure, which involves opening the intersphincteric space while preserving the external anal sphincter, or a Coring Out fistulectomy, which excises the fistula tract while maintaining sphincter integrity. Both procedures are performed surgically, with TROPIS including creation of a drainage gutter to aid healing. The study will compare outcomes such as failure rate, operative time, wound healing duration, and postoperative complications including fecal incontinence. During the study, participants will be monitored for up to four months after surgery. Assessments will include healing success, infection rates, bleeding, pain intensity, urinary retention, and time to resume normal activities. Researchers will also track hospitalization length and surgical site conditions. These evaluations will help determine the relative benefits and risks of each surgical technique for treating high anal fistulas.

TROPIS Versus Coring Out Fistulectomy in High Anal Fistula