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.
Age >18 years;
Primary rectal cancer staged as cT1-4aN0-3M0 (or ycT0-4aN0-2M0);
Histologically confirmed rectal adenocarcinoma based on endoscopic biopsy;
Tumor located ≤12 cm from the dentate line (based on endoscopy, digital rectal examination, and/or pelvic MRI);
Age ≥80 years;
Presence of a pre-existing diverting ileostomy or colostomy;
Peritumoral abscess or tumor perforation;
Distant metastases (M1) identified preoperatively and/or intraoperatively;
ANO Scientific and Practical Club for the Development of Modern Medical Technologies
Lead sponsor