TROPIS versus Coring-Out Fistulectomy for High Anal Fistulas
Official title: Early Results of Transanal Opening of the Intersphincteric Space (TROPIS) Versus Coring Out Fistulectomy in Management of High Anal Fistulas: A Randomized Clinical Trial
Run by Cairo University · NCT07334678 · Data updated 2026-11-12
This compares TROPIS and coring-out fistulectomy to see which heals high anal fistulas better and causes less fecal incontinence in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | Cairo University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cairo, Al-Manial Cairo) |
| Status | Recruiting |
| Started | July 8, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | May 27, 2026 |
| Trial ID | NCT07334678 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with high anal fistula involving more than one-third of the sphincter complex, either new or recurrent, without inflammatory bowel disease, malignancy, prior pelvic radiation, preexisting fecal incontinence, or levator ani injury.
✕Probably not a fit
Patients with low fistulas or fistulas caused by Crohn's disease, malignancy, trauma, prior radiation, or those with existing fecal incontinence or levator ani injury are excluded and unlikely to benefit from these procedures in this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective randomized clinical trial at Cairo University comparing two sphincter-preserving surgical techniques for high anal fistulas: Transanal Opening of the Intersphincteric Space (TROPIS) and coring-out fistulectomy. Eligible adult patients with high fistulas (involving more than one-third of the sphincter complex), whether primary or recurrent, are randomized to undergo one of the two procedures and followed postoperatively. The primary outcome is failure rate (nonhealing or recurrence), and secondary outcomes include operative time, wound healing time, and postoperative complications including fecal incontinence. Surgeries and follow-up are conducted at the Faculty of Medicine, Cairo University with predefined exclusions for fistulas secondary to Crohn's disease, malignancy, trauma, radiation, or patients with preexisting incontinence or levator ani injury.
Why it matters
Potential benefit: If TROPIS proves superior, patients could have fewer recurrences and lower rates of postoperative fecal incontinence while preserving sphincter function.
How similar studies have gone: Coring-out fistulectomy is a traditional sphincter-preserving approach with variable recurrence rates, while several recent case series report promising outcomes for TROPIS but randomized head-to-head evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with high anal fistula ( involving more than 1/3 of the sphincter complex), whether de novo or recurrent Exclusion Criteria: * Patients with fistula secondary to malignancy, inflammatory bowel disease, trauma or radiation * Patients with Low anal fistula * Patient with preoperative fecal incontinence * Previous levator ani muscle injury
Where it's running
-
Faculty of medicine Cairo University
Cairo, Al-Manial Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Ahmed Mohamed Abdelaal, Lecturer
- Email: drabdelaal90@gmail.com
- Phone: +201118732767
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.