Actively Recruiting
Early Results of Transanal Opening of the Intersphincteric Space (TROPIS) Versus Coring Out Fistulectomy in Management of High Anal Fistulas: A Randomized Clinical Trial
Led by Cairo University ยท Updated on 2026-05-27
64
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
High anal fistulas, which involve more than one-third of the anal sphincter complex, are difficult to treat surgically due to high recurrence rates and the risk of postoperative fecal incontinence. Researchers are comparing two sphincter-preserving techniques: the traditional Coring Out fistulectomy and the newer Transanal Opening of the Intersphincteric Space (TROPIS) method. This randomized clinical trial aims to evaluate the effectiveness, safety, and patient outcomes of these two treatments for managing high complex anal fistulas. Participants will receive either the TROPIS procedure, which involves opening the intersphincteric space while preserving the external anal sphincter, or a Coring Out fistulectomy, which excises the fistula tract while maintaining sphincter integrity. Both procedures are performed surgically, with TROPIS including creation of a drainage gutter to aid healing. The study will compare outcomes such as failure rate, operative time, wound healing duration, and postoperative complications including fecal incontinence. During the study, participants will be monitored for up to four months after surgery. Assessments will include healing success, infection rates, bleeding, pain intensity, urinary retention, and time to resume normal activities. Researchers will also track hospitalization length and surgical site conditions. These evaluations will help determine the relative benefits and risks of each surgical technique for treating high anal fistulas.
CONDITIONS
Brief Title
TROPIS Versus Coring Out Fistulectomy in High Anal Fistula
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with high anal fistula involving more than one-third of the sphincter complex, whether new or recurrent
You will not qualify if you...
- Patients with fistula caused by malignancy, inflammatory bowel disease, trauma, or radiation
- Patients with low anal fistula
- Patients with preoperative fecal incontinence
- Patients with previous levator ani muscle injury
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.
Duration - Surgery day and hospitalization period until discharge
Participants undergo either Transanal Opening of the Intersphincteric Space (TROPIS) or Coring Out Fistulectomy to treat high anal fistula.
1 surgical visit and hospital stay until discharge
Duration - Up to 4 months postoperatively
Participants are monitored for wound healing, complications, and recovery after surgery.
Visits at day 1, day 7, and additional follow-ups over 4 months
Trial Site Locations
Total: 1 location
1
Faculty of medicine Cairo University
Cairo, Al-Manial Cairo, Egypt, 11451
Actively Recruiting
Research Team
A
Ahmed Mohamed Abdelaal, Lecturer
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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