NCT07399353 Comparative Study: Fistula Rerouting vs. LIFT for High Perianal Fistula
| NCT ID | NCT07399353 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cairo University |
| Condition | High Perianal Fistula |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-28 |
| Primary Completion | 2026-05 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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.
Eligibility Criteria
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.