Three-week ileostomy closure after colorectal surgery: a multicenter randomized trial of technical and postoperative outcomes

BACKGROUND: The optimal timing of temporary ileostomy closure following restorative colorectal surgery remains controversial. Although previous randomized studies have demonstrated the feasibility of early closure in carefully selected patients, the influence of closure timing on operative complexity has not been prospectively evaluated. This multicenter randomized controlled trial compared a standardized 3-week ileostomy closure strategy with conventional delayed closure, with particular emphasis on technical and postoperative outcomes. METHODS: In this prospective multicenter randomized controlled trial, 224 patients undergoing restorative colorectal resection with temporary diverting ileostomy were randomized to either early ileostomy closure at 3 weeks (n = 112) or conventional delayed closure (n = 112). Eligibility for reversal required rigorous confirmation of anastomotic healing using standardized clinical and endoscopic assessment, with selective computed tomography using rectal contrast when clinically indicated. The primary outcome was operative complexity, evaluated using operative duration, intraoperative adhesion severity, and the requirement for extended adhesiolysis. Secondary outcomes included postoperative morbidity, Clavien-Dindo complication grade, length of hospital stay, readmission, reoperation, re-diversion, and delay in adjuvant chemotherapy. RESULTS: Baseline demographic, clinical, and operative characteristics were comparable between the study groups. Early ileostomy closure was associated with significantly shorter operative duration (90 ± 12 vs. 130 ± 18 min; P < 0.001), substantially lower intraoperative adhesion severity (P = 0.04), and a markedly reduced requirement for extended adhesiolysis (5.4% vs. 21.4%; P < 0.001). Overall postoperative morbidity, Clavien-Dindo grade distribution, postoperative length of stay, readmission, reoperation, and mortality were comparable between groups. Delays in adjuvant chemotherapy occurred only in the early-closure group (3.6%), were limited to 1-4 weeks, and all affected patients subsequently commenced the planned oncologic treatment. CONCLUSIONS: In carefully selected patients with confirmed anastomotic healing, 3-week ileostomy closure is a technically feasible and safe strategy following restorative colorectal surgery. Compared with conventional delayed closure, reversal at 3 weeks significantly reduced operative complexity without compromising short-term postoperative outcomes. These findings support selective implementation of a standardized 3-week ileostomy closure strategy and identify operative complexity as a key determinant when selecting the optimal timing of ileostomy reversal. GOV IDENTIFIER: NCT05192018.