Actively Recruiting
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
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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
Eligibility Criteria
You may qualify if you...
- Patients with high anal fistula from both gender
- Aged 18 years or older
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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