IFOC Compared With LIFT in High Anal Fistula

Early Outcomes of Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) Compared With Ligation of the Intersphincteric Fistula Tract (LIFT) in High Anal Fistula: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: High Anal Fistula; Anal Fistula Surgery
• Intervention / Treatment: Procedure: Intra-anal Fistulotomy With Fistula Opening Closure (IFOC); Procedure: Ligation of the Intersphincteric Fistula Tract (LIFT)

Detailed Description

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. High anal fistula is defined as involvement of more than one-third of the sphincter complex. Patients with inflammatory bowel disease, low anal fistula, fistula secondary to colorectal malignancy, pre-existing fecal incontinence, or previous levator ani muscle injury will be excluded. The study will be explained to eligible patients, and informed consent will be obtained.

All patients will undergo detailed history taking and clinical examination, including identification of internal and external openings, assessment of discharge, and evaluation of continence using the Jorge-Wexner incontinence score. MRI fistulogram will be performed preoperatively to define the fistulous tract and its relation to the sphincter complex.

Patients will be randomly allocated into two equal groups using a computer-generated sequence. Group A will undergo the LIFT procedure, while Group B will undergo the IFOC procedure.

In the LIFT procedure, the fistulous tract will be identified, dissected in the intersphincteric plane, ligated at two points, and divided. The external opening will be curetted and left for drainage. In the IFOC procedure, the tract will be identified and opened intra-anally, followed by curettage and closure of the internal opening with absorbable sutures, with drainage of the external tract.

Postoperatively, patients will resume oral intake within hours after surgery and are usually discharged on the first postoperative day. Follow-up will be conducted at regular intervals for at least six months to assess healing, continence, complications, and recurrence.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Mohamed Abdelaal, MD; Phone Number: +201118732767; Email: drabdelaal90@gmail.com

Study Locations

• Egypt
  • Al-Manial, Cairo, Egypt
    • Cairo, Al-Manial, Cairo, Egypt, Egypt, 11451
      • Recruiting
      • Faculty of Medicine, Cairo University
      • Contact: Ahmed Mohamed Abdelaal, MD; Phone Number: +201118732767; Email: drabdelaal90@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with high anal fistula from both gender

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-anal Fistulotomy With Fistula Opening Closure (IFOC); 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); 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.
Active Comparator: Ligation of the Intersphincteric Fistula Tract (LIFT); patient with high anal fistula will be treated with Ligation of the Intersphincteric Fistula Tract (LIFT)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative urine retention	compare postoperative urine retention in both groups	Within 48 hours postoperatively
Operative time	Compare time of operation between both procedure	During surgery
Postoperative fecal incontinence	Compare post postoperative fecal incontinence in both groups	Up to 6 months postoperatively
surgical site infection	compare surgical site infection in both groups (surgical site infection: infection at or near a surgical incision within 30 days post-surgery, marked by redness, swelling, or pus.)	Up to 6 months postoperatively
Time for wound Healing	Time for wound Healing in both 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)	Up to 6 months postoperatively
Postoperative bleeding	compare Postoperative bleeding in both groups	Up to 6 months postoperatively
Time to return to normal activity	Compare Time to return to normal activity in both groups	Up to 6 months postoperatively
Pain intensity	Compare Pain intensity measured using Visual Analogue Scale between both groups (Visual Analogue Scale for Pain: ranges from 0 to 10 . Higher scores indicate a worse outcome {greater pain intensity}).	At day 1 and day 7 postoperatively

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mohamed Yehia Elbarmalgi, MD, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: LIFT; High anal fistula; IFOC
• Other Study ID Numbers: N-58-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because this is a small surgical trial with a limited number of participants, and sharing raw data could lead to identification of participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No