PURPOSE: To identify the incidence of major fecal incontinence and recurrence after staged fistulotomy using a seton. METHODS: A five-year retrospective chart review of 116 patients (70 males and 46 females) ranging in age from 18 to 81 years (mean, 42 years), in whom setons were placed as part of a surgical procedure for anorectal fistulas, was carried out. Follow-up ranged from 2 to 61 months (mean, 23 months). RESULTS: Setons were employed to identify and promote fibrosis around a complex anorectal fistula as part of a staged fistulotomy in 65 patients (56 percent). Other indications for seton placement included 24 women with anteriorly situated high transsphincteric fistulas (21 percent) and three patients with massive anorectal sepsis (floating, freestanding anus) (2.5 percent). In addition, setons were used to preclude premature skin closure and promote controlled long-term fistula drainage in 21 patients with severe anorectal Crohn's disease (18 percent) and in three patients with AIDS (2.5 percent). Major fecal incontinence (requiring the use of a perineal pad) occurred in five patients (5 percent), and recurrent fistulas were noted in three (3 percent). CONCLUSIONS: Staged fistulotomy using a seton is a safe and effective method of treating high or complicated anorectal fistulas.