Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial.

OBJECTIVE The objective was to study morbidity and mortality associated with early closure (8-13 days) of a temporary stoma compared with standard procedure (closure after > 12 weeks) after rectal resection for cancer. BACKGROUND A temporary ileostomy may reduce the risk of pelvic sepsis after anastomotic dehiscence. However, the temporary ileostomy is afflicted with complications and requires a second surgical procedure (closure) with its own complications. Early closure of the temporary ileostomy could reduce complications for rectal cancer patients. METHODS Early closure (8-13 days after stoma creation) of a temporary ileostomy was compared with late closure (>12 weeks) in a multicenter randomized controlled trial, EASY (www.clinicaltrials.gov, NCT01287637) including patients undergoing rectal resection for cancer. Patients with a temporary ileostomy without signs of postoperative complications were randomized to closure at 8 to 13 days or late closure (>12 weeks after index surgery). Clinical data were collected up to 12 months. Complications were registered according to the Clavien-Dindo Classification of Surgical Complications, and Comprehensive Complication Index was calculated. RESULTS The trial included 127 patients in eight Danish and Swedish surgical departments, and 112 patients were available for analysis. The mean number of complications after index surgery up to 12 months follow up was significantly lower in the intervention group (1.2) compared with the control group (2.9), P < 0.0001. CONCLUSIONS It is safe to close a temporary ileostomy 8 to 13 days after rectal resection and anastomosis for rectal cancer in selected patients without clinical or radiological signs of anastomotic leakage.