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

What this Trial Is About

Researchers are evaluating treatments for high fistula-in-ano (FIA), a challenging condition for surgeons aiming to close fistulas while preserving continence. This trial compares two procedures: collagen paste injection and mucosal advancement flap, to see which better promotes fistula healing with fewer complications. The study addresses the need for effective, sphincter-preserving options due to limitations and side effects of current surgical methods. The trial involves two treatment groups. One group receives collagen paste injection after removal of a seton drain and de-epithelialisation of the fistula tract. This paste is a porcine-derived collagen matrix designed to promote healing and reduce dislodgement. The other group undergoes mucosal advancement flap surgery, where the internal fistula opening is excised and covered with a "U-shape" rectal mucosal flap. Both approaches aim to close the fistula while preserving anal sphincter function. Participants are adults diagnosed with high cryptoglandular fistula-in-ano who have been treated with a draining seton for at least six weeks. During the study, clinical healing of the fistula will be assessed at one year, along with secondary outcomes such as complications within 30 days, quality of life, pain after one week, fecal incontinence, and hospital readmission rates. The study includes follow-ups and monitoring to evaluate both effectiveness and safety over a year.

Collagen Paste vs Mucosal Advancement Flap for FIA