Collagen Paste vs Mucosal Advancement Flap for FIA
ConditionFistula-in-ano
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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
Qualifiers
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.
Disqualifiers
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.).
Trial design
Treatments tested in this trial
- Collagen Paste
- Mucosal advancement
Treatment groups
118 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov