IFOC Compared With LIFT in High Anal Fistula

Official title

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

Overview

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.

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.

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.

Primary outcome measures

• Assessment of failure rate of IFOC and LIFT procedures [Time frame: Up to 6 months postoperatively]

Secondary outcome measures (8)

• Operative time [Time frame: During surgery]
• surgical site infection [Time frame: Up to 6 months postoperatively]
• Time for wound Healing [Time frame: Up to 6 months postoperatively]
• Postoperative bleeding [Time frame: Up to 6 months postoperatively]
• Postoperative fecal incontinence [Time frame: Up to 6 months postoperatively]
• Time to return to normal activity [Time frame: Up to 6 months postoperatively]
• Postoperative urine retention [Time frame: Within 48 hours postoperatively]
• Pain intensity [Time frame: At day 1 and day 7 postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of medicine, Cairo University — Cairo

Identifiers

NCT: NCT07520500 · N-58-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗