Closure of Temporary Ileostomy 2 Versus 12 Weeks After Rectal Resection for Cancer: A Word of Caution From a Prospective, Randomized Controlled Multicenter Trial

Abstract

BACKGROUND: The optimum timing for temporary ileostomy closure after low anterior resection is still open. OBJECTIVE: This trial aimed to compare early (2 wk) versus late (12 wk) stoma closure. DESIGN: The study included 2 parallel groups in a multicenter, randomized controlled clinical trial. SETTINGS: The study was conducted at 3 Swiss hospitals. PATIENTS: Patients undergoing low anterior resection and temporary ileostomy for cancer were included. INTERVENTIONS: Patients were randomly allocated to early or late stoma closure. Before closure, colonic anastomosis was examined for integrity. MAIN OUTCOME MEASURES: The primary efficacy outcome was the Gastrointestinal Quality of Life Index 6 weeks after resection. Secondary end points included safety (morbidity), feasibility, and quality of life 4 months after low anterior resection. RESULTS: The trial was stopped for safety concerns after 71 patients were randomly assigned to early closure (37 patients) or late closure (34 patients). There were comparable baseline data between the groups. No difference in quality of life occurred 6 weeks (mean Gastrointestinal Quality of Life Index: 99.8 vs 106.0; p = 0.139) and 4 months (108.6 vs 107.1; p = 0.904) after index surgery. Intraoperative tendency of oozing (visual analog scale: 35.8 vs 19.3; p = 0.011), adhesions (visual analog scale: 61.3 vs 46.2; p = 0.034), leak of colonic anastomosis (19% vs 0%; p = 0.012), leak of colonic or ileal anastomosis (24% vs 0%; p = 0.002), and reintervention (16% vs 0%; p = 0.026) were significantly higher after early closure. The concept of early closure failed in 10 patients (27% vs 0% in the late closure group (95% CI for the difference, 9.4%-44.4%)). LIMITATIONS: The trial was prematurely stopped because of safety issues. The aimed group size was not reached. CONCLUSIONS: Early stoma closure does not provide better quality of life up to 4 months after low anterior resection but is afflicted with significantly adverse feasibility and higher morbidity when compared with late closure.