Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07520500

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

Led by Cairo University · Updated on 2026-05-22

66

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two surgical procedures, Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) and Ligation of the Intersphincteric Fistula Tract (LIFT), in patients with high anal fistula, a condition involving more than one-third of the sphincter complex. This pilot randomized controlled trial aims to compare early outcomes such as failure rates, healing, continence, and complications in patients treated for this condition. Participants will be randomly assigned to one of two groups: one group will undergo the LIFT procedure, where the fistulous tract is dissected, ligated, and divided, while the other group will receive the IFOC procedure, involving intra-anal fistulotomy, curettage, closure of the internal opening, and drainage. Both procedures follow standard surgical techniques. Postoperative care includes early oral intake and planned discharge on the first day after surgery, with follow-up visits scheduled for at least six months to monitor recovery and detect any complications or recurrence. During the study, participants will have comprehensive assessments including medical history, clinical examination identifying fistula openings, discharge evaluation, and continence scoring using the Jorge-Wexner incontinence score. MRI fistulogram will be used preoperatively to map the fistula tract. Follow-up visits at 1 week, 2 weeks, 1 month, and monthly thereafter will assess healing, surgical site infection, pain, bleeding, incontinence, urine retention, and time to return to normal activities. The main outcome measured is the failure rate of the two procedures up to six months after surgery.

CONDITIONS

Brief Title

IFOC Compared With LIFT in High Anal Fistula

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with high anal fistula from both gender
  • Aged 18 years or older
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day for surgery with immediate discharge usually on the first postoperative day

Participants will undergo one of two surgical procedures for high anal fistula: either Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) or Ligation of the Intersphincteric Fistula Tract (LIFT).

1 surgical visit

Post-operative Follow-up

Duration - Up to 6 months

Participants will be followed for at least six months after surgery to assess healing, continence, complications, and recurrence.

Regular follow-up visits over 6 months

Trial Site Locations

Total: 1 location

1

Faculty of medicine, Cairo University

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

Actively Recruiting

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Research Team

A

Ahmed Mohamed Abdelaal, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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