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

NCT07399353 | Recruiting

• 1 other identifier: MS-312-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

High Perianal Fistula

Keywords

Fistula rerouting; LIFT (Ligation of Intersphincteric Fistula Tract); High perianal fistula; Anal fistula surgery; Sphincter-saving surgery; Fecal incontinence; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Fistula Recurrence Rate

  The proportion of patients in each group with clinically confirmed recurrence of the perianal fistula within 6 months postoperatively. Recurrence is defined as the reappearance of symptoms (pain, discharge) and/or a confirmed tract on postoperative MRI fistulogram.

  Within 3 months after the final surgical procedure

• Postoperative Fecal Incontinence

  Change in anal continence status assessed using the Cleveland Clinic Fecal Incontinence Score (CCFIS). The score ranges from 0 (perfect continence) to 20 (complete incontinence). A higher score indicates worse function. Incontinence is defined as a CCFIS ≥ 5.

  At 3 months postoperatively

Secondary Outcomes (3)

• Time to Complete Wound Healing

  From the date of surgery until the date of documented complete healing, assessed up to 3 months

• Postoperative Wound Infection Rate

  Within 6 weeks postoperatively

• Postoperative Pain

  At 1 week and 2 weeks postoperatively

Study Arms (2)

Fistula Rerouting Technique Group

EXPERIMENTAL

Participants in this group will undergo a staged Fistula Rerouting procedure. First Stage: The fistulous tract is cored out using diathermy. Dissection is continued until the point where the tract traverses the external anal sphincter. A circumanal incision is made at the anal verge over this point. The intersphincteric space is entered and dissected until the fistulous tract is palpable. The tract is then dissected off the external sphincter via muscle-splitting and transposed into the intersphincteric space. The original defect in the external sphincter is closed with interrupted absorbable sutures. If the transposed tract is too long, its distal portion is excised. A seton may be placed in the new intersphincteric tract to mark it for the second stage, provided this does not risk injury to the mobilized tract. Second Stage: After complete healing of the first-stage wound (typically several weeks later), a fistulotomy is performed on the new, transposed intersphincteric tract

Procedure: Fistula Rerouting Technique

LIFT Technique Group

EXPERIMENTAL

Participants in this group will undergo the Ligation of Intersphincteric Fistula Tract (LIFT) procedure. A curvilinear incision is then made in the intersphincteric groove (the groove between the internal and external anal sphincters) overlying the identified tract. Dissection proceeds through the intersphincteric plane until the mature, fibrous fistula tract is encountered. The tract is carefully isolated, then divided. Both the internal (toward the anal canal) and external (toward the skin) ends of the divided tract are securely ligated (tied off) with suture material. The infected cryptoglandular tissue surrounding the tract is debrided and removed. The internal wound (near the anal canal) and the external wound (in the intersphincteric groove) are debrided and left open to heal by secondary intention, ensuring adequate drainage.

Procedure: Ligation of Intersphincteric Fistula Tract

Interventions

Fistula Rerouting Technique PROCEDURE

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.

Fistula Rerouting Technique Group

Ligation of Intersphincteric Fistula Tract PROCEDURE

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.

LIFT Technique Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, Al-Manial Cairo, 11956, Egypt

RECRUITING

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Mostafa Mohamed Sedky, Lecturer

CONTACT

+201066016961; mostafa_mohamed720@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: August 28, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)