This Study Compares the Conventional Cutting Seton Technique and a GLUBRAN®-Coated Seton in High … (NCT07676825) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
This Study Compares the Conventional Cutting Seton Technique and a GLUBRAN®-Coated Seton in High Perianal Fistula Treatment. The Study Aims to Determine Whether the GLUBRAN®-Coated Seton Improves Healing, Reduces Postoperative Pain and Recurrence, and Better Preserves Anal Continence.
Egypt36 participantsStarted 2026-01-11
Plain-language summary
High anal fistula is a complex anorectal condition that can cause persistent pain, purulent discharge, recurrent infection, and a significant reduction in quality of life. The conventional cutting seton technique is an established treatment modality; however, it may be associated with postoperative pain, delayed healing, recurrence, and impairment of anal continence. GLUBRAN® is a synthetic surgical adhesive with antimicrobial and tissue-healing properties that may enhance the performance of the cutting seton and improve clinical outcomes.
This randomized controlled clinical trial aims to compare the efficacy and safety of a conventional cutting seton with a GLUBRAN®-coated cutting seton in adult patients with high anal fistulas. Eligible participants will be randomly allocated to one of the two treatment groups and followed for six months after surgery. The primary and secondary outcome measures will include fistula healing rate, time to complete healing, postoperative pain, anal continence, recurrence, postoperative complications, and length of hospital stay.
The findings of this study may provide evidence regarding whether coating a cutting seton with GLUBRAN® offers clinical advantages over the conventional technique, potentially leading to improved healing, reduced postoperative morbidity, and better preservation of anal continence in the management of high anal fistulas.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: - Patients diagnosed with high trans-sphincteric/Extrasphinteric/supra-sphincteric/complex Fistula confirmed clinically and MRI Fistulogram
* Age ≥ 18 years
* Patients fit for surgery.
Exclusion Criteria:
* Patients with Crohn's disease, tuberculosis, malignancy, or radiation-associated fistulas (due to different healing patterns and management protocols).
* Presence of acute perianal abscess at the time of surgery
* Patients with uncontrolled comorbidities (e.g., diabetes mellitus, bleeding disorders, immunosuppression) that could affect healing.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.