NCT06386835 Collagen Paste vs Mucosal Advancement Flap for FIA
| NCT ID | NCT06386835 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Fistula-in-ano |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2024-01-26 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 118 participants in total. It began in 2024-01-26 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 a fistula plug.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06386835 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fistula-in-ano. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06386835 currently recruiting?
Yes, NCT06386835 is actively recruiting participants. Contact the research team at kfutaba@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT06386835 trial being conducted?
This trial is being conducted at Shatin, Hong Kong, Shatin, Hong Kong.
Who is sponsoring the NCT06386835 clinical trial?
NCT06386835 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 118 participants.