RecruitingNot ApplicableNCT06386835

Collagen Paste vs Mucosal Advancement Flap for FIA

Collagen Paste Injection Compared With Mucosal Advancement Flap for the Treatment of Fistula-in-ano: Single Centre Non-inferiority Randomised Controlled Trial

Sponsor

Chinese University of Hong Kong

Enrollment

118 participants

Start Date

Jan 26, 2024

Study Type

INTERVENTIONAL

Conditions

Fistula in Ano

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria10

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.