OBJECTIVE: To assess the efficacy of a staged strategy for the treatment of complex perianal fistula. METHODS: Between January 1999 and April 2003 all consecutive patients with complex perianal fistulas were treated according to a staged strategy. Fistula tracks originating from the middle third or upper part of the anal sphincter were included. Patients were examined for recurrent fistulas and complaints of incontinence and soiling. Initial treatment consisted of a noncutting seton with or without a diverting stoma. Definitive surgical treatment consisted of an advancement flap or fistulotomy. RESULTS: Thirty patients were included (median age; 42 years, range 22-68 years). Seven had Crohn's disease without signs of rectal and anal involvement other than the fistula. At a median follow up of 22 months (range 8-52 months) in 29 (97%) patients, the wounds had healed completely; 7 (22%) patients subsequently developed a recurrent fistula and minor soiling occurred in 7 (23%) patients. CONCLUSION: Initial treatment with a seton with and without a diverting stoma minimizing inflammatory activity at the fistula site before definitive surgical treatment gave good results in this difficult group of patients.