REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department

The purpose of this multicenter randomized non-inferiority trial is to evaluate the safety of low anterior resection for rectal cancer performed with versus without a diverting stoma in patients with a low predicted risk of colorectal anastomotic leakage. The primary objective is to determine whether the rate of anastomotic leakage within 30 days after surgery in the no-stoma group is non-inferior to that in the diverting stoma group. The secondary objectives include comparison between groups regarding: Stoma rate at 1 year after surgery; Quality of life at 30 days and 1 year (EORTC QLQ-C30, EORTC QLQ-CR29, and LARS score); Short-term postoperative outcomes, including postoperative day metrics, length of hospital stay, and complications graded according to the Clavien-Dindo classification; Reoperation rates within 30 days and 1 year. Participants will include adult patients with mid- or low-rectal adenocarcinoma who are scheduled for radical minimally invasive total mesorectal excision and have a predicted risk of anastomotic leakage \<10% according to the study risk model.

NCT Number	NCT07463261
Lead Sponsor	ANO Scientific and Practical Club for the Development of Modern Medical Technologies
Conditions	TME, Rectal Cancer Surgery, Low Rectal Cancer, Middle Rectal Cancer, Local Advanced Rectal Cancer
Enrollment	442 participants
Start Date	2026-05-05
Primary Completion	2027-06-10 (estimated)
Study Completion	2027-06-10 (estimated)
Updated on ClinicalTrials.gov	2026-05-13