Randomized clinical trial of early versus delayed temporary stoma closure after proctectomy

Abstract Background Temporary faecal diversion is recommended with a low colorectal, coloanal or ileoanal anastomosis (LA). This randomized study evaluated early (EC; 8 days) versus late (LC; 2 months) closure of the temporary stoma. Methods Patients undergoing rectal resection with LA were eligible to participate. If there was no radiological sign of anastomotic leakage after 7 days, patients were randomized to EC or LC. The primary endpoints were postoperative morbidity and mortality 90 days after the initial resection. Results Some 186 patients were analysed. There were no deaths within 90 days and overall morbidity rates were similar in the EC and LC groups (31 versus 38 per cent respectively; P = 0·254). Overall surgical complication (both 15 per cent; P = 1·000) and reoperation (both 8 per cent; P = 1·000) rates were similar, but wound complications were more frequent after EC (19 versus 5 per cent; P = 0·007). Small bowel obstruction (3 versus 16 per cent; P = 0·002) and medical complications (5 versus 15 per cent; P = 0·021) were more common with LC. Median (range) hospital stay was reduced by EC (16 (6–59) versus 18 (9–262) days; P = 0·013). Conclusion Early stoma closure is feasible in selected patients, with reduced hospital stay, bowel obstruction and medical complications, but a higher wound complication rate. Registration number: NCT00428636 (http://www.clinicaltrials.gov).