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

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: Sonic 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 LC (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).