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IFOC Compared With LIFT in High Anal Fistula

NCT07520500 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-05-22

No results posted yet for this study

Summary

Patients presenting to the outpatient clinic at Kasr Al-Ainy Hospitals with high anal fistula will be assessed according to the inclusion and exclusion criteria. The study purpose will be explained, and informed consent will be obtained from eligible participants. A detailed medical history and routine preoperative assessment will be conducted.

Clinical evaluation will include identification of the internal and external openings, assessment of discharge, and continence status using the Jorge-Wexner incontinence score. MRI fistulogram will be performed preoperatively to evaluate the fistula tract and its relation to the sphincter complex.

Patients will be randomly allocated into two equal groups (1:1 ratio) using a computer-generated sequence:

Group A: Undergo LIFT procedure Group B: Undergo IFOC procedure Both procedures will be performed as per standard surgical techniques. Postoperatively, patients will start oral fluids after 2 hours and resume a normal diet as tolerated. Discharge is planned on the first postoperative day unless otherwise indicated. Follow-up will be conducted at 1 week, 2 weeks, 1 month, and monthly thereafter for at least 6 months to assess healing and detect complications, including recurrence.

Conditions

  • Anal Fistula Surgery
  • High Anal Fistula

Interventions

PROCEDURE

Intra-anal Fistulotomy With Fistula Opening Closure (IFOC)

The fistulous tract was identified using an arterial clamp and confirmed by water injection. Intra-anal fistulotomy was performed with electrocautery, followed by curettage of granulation tissue. The internal opening was closed with absorbable sutures in a horizontal mattress fashion, with closure confirmed by water injection. The external tract was further curetted, a tube drain was inserted, and reinforcing sutures were applied to promote healing.

PROCEDURE

Ligation of the Intersphincteric Fistula Tract (LIFT)

The internal opening was identified by injection through the external opening. The tract was dissected in the intersphincteric plane, ligated at two points, and divided. Closure was confirmed by reinjection, the external opening was curetted and drained, and the incision was loosely closed.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Mohamed Yehia Elbarmalgi, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-19
Primary Completion
2027-04-01
Completion
2027-04-01

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 NCT07520500 on ClinicalTrials.gov