BackgroundThe optimal surgical treatment for high transsphincteric fistula-in-ano (FIA) should attain complete eradication of the fistulous track and, in the same time, not compromising the anal sphincters. The present study aimed to investigate the predictive factors for recurrence of high transsphincteric FIA after placement of draining seton and to evaluate the efficacy and complications of seton treatment for high cryptoglandular anal fistula. Materials and methodsThis is a retrospective case–control study of patients with high transsphincteric FIA who were treated with seton placement. Variables analyzed were the characteristics of FIA, incidence of recurrence, postoperative complications including fecal incontinence (FI), and the predictive factors for recurrence. ResultsA total of 251 patients (232 males) with high transsphincteric FIA were treated with loose seton placement. Patients were followed for a median period of 16 mo. Recurrence of FIA was recorded in 26 of patients (10.3%) after a mean duration of 12.2 ± 3.9 mo of seton removal. Previously recurrent fistula (odds ratio [OR] = 2.81, P = 0.02), supralevator extension (OR = 3.19, P = 0.01) and anterior fistula (OR = 3.36, P = 0.004), and horseshoe fistula (OR = 5.66, P = 0.009) were the most significant predictors of recurrence. FI was detected in eight patients (3.2%). Female gender (OR = 15.2, P = 0.0003) and horseshoe fistula (OR = 8.66, P = 0.01) were the significant risk factors for FI after the procedure. ConclusionsSignificant risk factors for recurrence of FIA were previous fistula surgery, anterior anal fistula, and presence of secondary tracks or branches as supralevator extension, and horseshoe fistula.