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

NCT07399353 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

  • High Perianal Fistula

Interventions

PROCEDURE

Fistula Rerouting Technique

A two-stage, sphincter-preserving surgical procedure for high perianal fistula. Stage 1: The native fistulous tract is surgically dissected and transposed from its trans-sphincteric course into the intersphincteric plane. The defect in the external sphincter is repaired. Stage 2: After complete healing of the first-stage wound, a fistulotomy is performed on the newly created intersphincteric tract. The goal is to eradicate the fistula while minimizing injury to the anal sphincter complex.

PROCEDURE

Ligation of Intersphincteric Fistula Tract

A single-stage, sphincter-preserving surgical procedure for perianal fistula. The fistula tract is accessed via an incision in the intersphincteric groove. The tract is identified, dissected, divided, and both ends are ligated. The infected cryptoglandular tissue is excised. The internal and external wounds are debrided and left open to heal by secondary intention. The goal is to close the fistula tract at its origin while preserving sphincter function.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07399353 on ClinicalTrials.gov