RecruitingNot Applicable

Comparative Study: Fistula Rerouting vs. LIFT for High Perianal Fistula

Egypt40 participantsStarted 2025-08-28

Plain-language summary

The goal of this clinical trial is to compare two different surgery methods for treating a complex type of anal fistula. This condition is an abnormal tunnel connecting the inside of the anus to the skin nearby. The main questions the study aims to answer are: Which surgery has a lower chance of the fistula coming back (recurrence)? Which surgery has a lower chance of causing problems with bowel control (incontinence) after healing? Researchers will compare two surgery groups: Group 1: Fistula Rerouting Technique - a two-step surgery that moves the fistula tract to a safer area before opening it. Group 2: LIFT Technique - a surgery that ties off and closes the fistula tract from between the anal muscles. Participants will be randomly assigned by a computer to one of these two surgery groups. This helps ensure the comparison between the two surgeries is fair. Participants in this study will: * Have tests before surgery, including an MRI scan, to confirm they have the specific type of fistula being studied. * Undergo one of the two planned surgical procedures. * Attend follow-up visits after surgery at 1 week, 2 weeks, 1 month, and 3 months. * Be checked during these visits for wound healing, pain, infection, and bowel control. * Have another MRI scan if the fistula is suspected to have come back.

Who can participate

Age range

20 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients (age 20-65 years) presenting with a high perianal fistula, defined as:Trans-sphincteric fistula tract traversing the upper two-thirds of the external anal sphincter, Or Extrasphincteric fistula. * Patients with recurrent perianal fistula. * Ability to provide informed consent. Exclusion Criteria: * Patients with preoperative fecal incontinence (as assessed by the Cleveland Clinic Fecal Incontinence Score). * Diagnosis of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). * Pregnant women. * Pediatric patients (age \< 20 years). * Patients with complex, branching fistula tracts. * Any contraindication to spinal/general anesthesia or surgery.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fistula Recurrence Rate

Timeframe: Within 3 months after the final surgical procedure

Postoperative Fecal Incontinence

Timeframe: At 3 months postoperatively

Trial details

NCT IDNCT07399353

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Mostafa Mohamed Sedky, Lecturer

+201066016961 mostafa_mohamed720@yahoo.com

View on ClinicalTrials.gov More High Perianal Fistula trials