IFOC Compared With LIFT in High Anal Fistula

NCT07520500 | Recruiting

• 1 other identifier: N-58-2026
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

High anal fistula; IFOC; LIFT

Outcome Measures

Primary Outcomes (1)

• Assessment of failure rate of IFOC and LIFT procedures

  Assessment of failure rate, defined as failure of healing or recurrence of anal fistula during the follow-up period, in both treatment groups. (Healing is defined as: Complete closure of the external opening, Absence of pus discharge , Absence of local pain or inflammation and No detectable tract on examination ) (Recurrence is defined as: Reappearance of discharge from the previous external opening after initial healing, or development of a new fistulous opening at or near the surgical site.)

  Up to 6 months postoperatively

Secondary Outcomes (8)

• Operative time

  During surgery

• surgical site infection

  Up to 6 months postoperatively

• Time for wound Healing

  Up to 6 months postoperatively

• Postoperative bleeding

  Up to 6 months postoperatively

• Postoperative fecal incontinence

  Up to 6 months postoperatively

Study Arms (2)

Intra-anal Fistulotomy With Fistula Opening Closure (IFOC)

EXPERIMENTAL

Patient with high anal fistula will be treated with Intra-anal Fistulotomy With Fistula Opening Closure (IFOC)

Procedure: Intra-anal Fistulotomy With Fistula Opening Closure (IFOC)

Ligation of the Intersphincteric Fistula Tract (LIFT)

ACTIVE COMPARATOR

patient with high anal fistula will be treated with Ligation of the Intersphincteric Fistula Tract (LIFT)

Procedure: Ligation of the Intersphincteric Fistula Tract (LIFT)

Interventions

Ligation of the Intersphincteric Fistula Tract (LIFT) PROCEDURE

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.

Ligation of the Intersphincteric Fistula Tract (LIFT)

Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) PROCEDURE

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.

Intra-anal Fistulotomy With Fistula Opening Closure (IFOC)

Eligibility Criteria

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

You may qualify if:

• Patients with high anal fistula from both gender

You may not qualify if:

• Patient with preoperative fecal incontinence
• Fistula secondary to colorectal malignancy
• Patients with inflammatory bowel disease
• Fistula secondary to trauma or radiation
• Low anal fistula

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine, Cairo University

Cairo, Al-Manial, Cairo, Egypt, 11451, Egypt

RECRUITING

Study Officials

• Mohamed Yehia Elbarmalgi, MD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Mohamed Abdelaal, MD

CONTACT

+201118732767; drabdelaal90@gmail.com

Study Design

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

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: April 19, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)