Randomized trial of loop ileostomy in restorative proctocolectomy.

A randomized controlled trial was performed to assess the role of loop ileostomy in totally stapled restorative proctocolectomy. Entry criteria included all patients who were not on corticosteroids in whom on-table testing revealed a watertight pouch with intact ileoanal anastomosis. Of 59 patients undergoing restorative proctocolectomy over 36 months, 45 were eligible and were randomized to loop ileostomy (n = 23) or no ileostomy (n = 22). The age and diagnosis of the groups were similar. There were no deaths; two ileoanal anastomotic leaks occurred, one in each group. Ileoanal stenosis occurred in five patients with and one without an ileostomy. The incidences of wound and pelvic sepsis, bowel obstruction and pouchitis were similar. Twelve patients (52 per cent) developed ileostomy-related complications. The median total hospital stay was 23 (range 13-75) days with ileostomy and 13 (range 7-119) days without (P < 0.001). This study indicates that there is a low risk of pelvic sepsis which is not increased by avoiding a protective ileostomy. Loop ileostomy was associated with a high incidence of complications.