Early versus standard closure of temporary ileostomy in patients with rectal cancer: A randomized controlled trial

Background and Objectives A significant proportion of patients undergoing rectal cancer surgery receive a temporary ileostomy because of its benefits in case of anastomotic dehiscence. However, the best timing for closure remains unclear. Methods Early closure (EC; 30 days after creation) and standard closure (SC; 90 days after creation) of ileostomy were compared in a single-center randomized controlled trial conducted at National Cancer Institute (Vilnius, Lithuania). Patients with a temporary ileostomy who underwent rectal cancer surgery and did not have anastomotic leakage or other serious complications were randomized to early or standard ileostomy closure groups. Thirty days postoperative morbidity following ileostomy closure was the primary outcome of the study. Results The trial was prematurely terminated due to the safety reason after 86 patients were randomized to EC (43 patients) and SC (43 patients) groups. The overall 30 days postoperative morbidity rate was dramatically higher in the EC group (27.9% vs 7.9%; P = 0.024). Moreover, severe complications (Clavien-Dindo >= 3) were present only after EC of ileostomy in five (11.6%) patients. Conculsion Early closure of ileostomy at 30 days after radical rectal resection is not safe and should not be performed.