Collagen Paste vs Mucosal Advancement Flap for FIA (NCT06386835) | Clinical Trial Compass
RecruitingNot Applicable
Collagen Paste vs Mucosal Advancement Flap for FIA
Hong Kong118 participantsStarted 2024-01-26
Plain-language summary
The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano.
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:
* Clinical diagnosis of high cryptoglandular fistula-in-ano.
* Patients must have undergone a prior EUA to characterise the nature of the fistula.
* The fistula tract should be ≥ 2 cm in length.
* Only a single internal fistula opening should be present at EUA, such that the fistula is suitable for treatment by insertion of a seton drain.
* Patients must have been treated with a draining seton for a minimum period of 6 weeks prior to randomisation.
* Patients must be aged ≥ 18 years and able to provide informed consent.
* Fistulas must be of cryptoglandular aetiology.
Exclusion Criteria:
* Unable/unwilling to provide informed consent.
* Contraindication to general anaesthesia or spinal anaesthesia.
* Low trans-sphincteric fistulas.
* Non-cryptoglandular fistulas (e.g. Crohn's disease, obstetric, irradiation, malignant, etc.).
* Other perineal fistulas (e.g. rectovaginal fistulas, pouch-vaginal fistulas, etc.).
* Complex disease in which more than one internal fistula opening is present and requiring concurrent insertion of more than one fistula plug.
* Clinical evidence of active perianal sepsis. In the event that there is disagreement between clinical and radiological assessment of active sepsis/collection, the clinical opinion will prevail.
* Cultural or religious objection to the use of pig tissue.
* Absolute contraindication to magnetic resonance imaging (MRI) (e.g. cardiac pacemaker).
* Patients with recurrent anal fistulas previously treated with …
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.