Comparing IFOC and LIFT surgery for 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
This will test whether IFOC or LIFT surgery leads to better healing and continence for people with high anal fistula.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cairo, Al-Manial, Cairo, Egypt) |
| Trial ID | NCT07520500 on ClinicalTrials.gov |
What this trial studies
Adults presenting with high anal fistula at Kasr Al-Ainy Hospitals will be screened and have preoperative MRI fistulogram and continence scoring. Eligible participants will be randomly assigned 1:1 to receive either the LIFT procedure or the intra-anal fistulotomy with fistula opening closure (IFOC) using standard surgical techniques. Postoperative care will follow the same protocol for both groups with clinical follow-up to document healing, discharge, and continence using the Jorge-Wexner score. Patients with inflammatory bowel disease, colorectal malignancy, pre-existing fecal incontinence, traumatic or radiation-related fistula, or low fistulas are excluded.
Who should consider this trial
Good fit: Adults of any gender with a high anal fistula (involving more than one-third of the sphincter complex) who do not have inflammatory bowel disease, colorectal cancer, prior fecal incontinence, or fistulas caused by trauma or radiation.
Not a fit: Patients with IBD, fistulas from cancer, pre-existing fecal incontinence, low anal fistulas, or those unable to attend follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the comparison could identify the approach that best heals fistulas while preserving bowel continence.
How similar studies have performed: Previous studies of LIFT have generally shown good continence preservation with variable healing rates, while intra-anal closure approaches have produced mixed results, so comparative data are available but not definitive.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cairo, Al-Manial, Cairo, Egypt
- Faculty of medicine, Cairo University — Cairo, Al-Manial, Cairo, Egypt, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed Mohamed Abdelaal, MD
- Email: drabdelaal90@gmail.com
- Phone: +201118732767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.