Gastrointestinal Fistula Clinical Trials

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Comparative Study Between Fistula Rerouting Technique and Ligation of Intersphincteric Fistula Tract (LIFT) Technique in Treatment of High Perianal Fistula.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Faculty of Medicine Cairo University
RECRUITING
Cairo
Contact Information
Primary
Mostafa Mohamed Sedky, Lecturer
mostafa_mohamed720@yahoo.com
+201066016961
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2026-06
Participants
Target number of participants: 40
Treatments
Experimental: Fistula Rerouting Technique Group
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
Experimental: LIFT Technique Group
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.
Related Therapeutic Areas
Sponsors
Leads: Cairo University

This content was sourced from clinicaltrials.gov