Fistula-in-ano in Infants and Children: Prospective, Randomized Clinical Trial on the Duration of Non-cutting Seton Placement

What this Trial Is About

This research evaluates the duration of non-cutting seton placement in infants and children with fistula-in-ano. The study is prospective and randomized, aiming to compare the outcomes of two different treatment durations in patients who receive a silicon seton for fistula-in-ano. It is sponsored by Friedrich-Alexander-Universite4t Erlangen-Nfcrnberg and includes patients up to 18 years old. Patients undergo treatment involving placement of a silicone non-cutting seton under general anesthesia, following institutional guidelines. The fistulous tract is identified and a silicon vessel loop is placed and secured loosely outside the anus. Participants are then randomized into one of two groups: one group has the seton in place for 4 weeks, and the other for 12 weeks. If a perianal abscess is present, drainage and sphincter-sparing debridement occur before wound healing. During the study, participants are monitored for recurrence of fistula-in-ano and perianal abscess at 6 months after the initial surgery. The study involves informed consent before participation and does not include blinding. Participants are followed to observe the primary outcomes related to recurrence. The total duration and detailed follow-up are structured to ensure safety and thorough evaluation of treatment effectiveness.

Fistula-in-ano in Infants and Children