Loose Seton Prior to Surgery for Single-tract Cryptoglandular Fistula vs no Seton

Cryptoglandular anal fistulas can cause pain, discharge, recurrent infection, and a prolonged treatment course. In current practice, patients with a single-tract mid-high or high cryptoglandular anal fistula often first undergo placement of a loose seton before definitive sphincter-preserving surgery. Although this staged approach is widely used, high-quality evidence showing that preoperative seton placement improves healing or other patient outcomes is limited. The SETON trial is a multicenter, randomized, controlled non-inferiority trial that compares two accepted treatment strategies: loose seton placement for approximately 8 weeks followed by definitive sphincter-preserving surgery versus direct sphincter-preserving surgery without prior seton placement. The study aims to determine whether omitting routine seton placement is not inferior in terms of fistula closure 26 weeks after t