Randomized trial of fecal diversion for sphincter repair

PURPOSE: Fecal diversion for sphincter repair is controversial. This randomized trial assessed whether fecal diversion would improve primary wound healing and functional outcome after sphincter repair. METHODS: Thirty-three patients with fecal incontinence requiring sphincter repair were recruited, but only 27 agreed to be randomly assigned to a defunctioning stoma (n=13) or no stoma (n=14). Patients were assessed by the Cleveland Clinic Incontinence Score (0–20) and anal physiology; the mean follow-up was 34 (range, 16–47) months. RESULTS: Incontinence score improved significantly in both groups (stoma, 13.5–7.8;P = 0.0072; no stoma, 14–9.6;P=0.0470): No difference was found between the two groups. Maximum resting pressure and maximum squeeze pressure increased significantly only in the no-stoma group (maximum resting pressure, 52.4–71.3 cm H₂O; maximum squeeze pressure, 87.3–100.7 cm H₂O;P<0.0001). There was no significant difference in functional outcome (stoma, 7.8; no stoma, 9.6;P=0.4567) or the number with complications of sphincter repair (stoma, 5; no stoma, 3;P=0.4197). However, stoma-related complications occurred in 7 of 13 patients having a stoma (parastomal hernia, 2; prolapsed stoma, 1; incisional hernia at the stoma site requiring repair, 5; and wound infection at the closure site, 1). CONCLUSION: Fecal diversion in sphincter repair is unnecessary, because it gives no benefit in terms of wound healing or functional outcome, and it is a source of morbidity.