PURPOSE: This study was designed to assess the healing rate of complex perianal fistulas in Crohn's disease after a multistep strategy, including induction treatment with Infliximab in case of active proctitis, followed by definitive surgery. METHODS: From 2000 to 2003, all consecutive patients with complex fistulas and Crohn's disease underwent pretreatment with noncutting setons and, in case of severe recurrent fistulas or abscesses, a diverting stoma. Infliximab was added in cases of active proctitis. After definitive surgical treatment, patients were examined. RESULTS: Seventeen patients were included (median age, 34 (range, 22-58) years). Seven patients were treated by surgery only, and in ten patients Infliximab was added. After a median follow-up of 19 (range, 8-40) months, fistula healing was observed in 17 patients (100 percent). One patient of the Infliximab group developed a recurrent fistula (10 percent) after 24 months, and in one patient (10 percent) soiling occurred. Two patients of the surgical group developed a recurrent fistula (29 percent) and soiling occurred in two patients (29 percent). CONCLUSIONS: A multistep strategy followed by definitive surgery for the treatment of complex perianal fistulas in patients with Crohn's disease is a promising treatment modality. The preliminary results of this study suggest that Infliximab treatment has a beneficial additive effect in the multistep treatment followed by definitive surgery of complex anal fistulas and active proctitis in Crohn's disease.