NCT07463261 REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department

Eligibility & Interventions

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This trial targets 442 participants in total. It began in 2026-05-05 with a primary completion date of 2027-06-10.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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); * Planned radical minimally invasive (laparoscopic/robot-assisted) intervention with TME and formation of primary colorectal/colonanal anastomosis; * Adequate hematologic function: hemoglobin ≥100 g/L, leukocytes \>4 × 10\^9/L, platelets \>100 × 10\^9/L; * Adequate renal function: serum creatinine \<150 µmol/L; * Adequate hepatic function: AST/ALT \<100 U/L; * Predicted risk of anastomotic leakage ≤10% (AFOR 0-1). Exclusion Criteria: * 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; * Synchronous or metachronous malignancy; * Prior pelvic irradiation for another condition (e.g., cervical or prostate cancer); * Evidence of malnutrition (serum albumin \<34 g/L); * Severe uncontrolled comorbid conditions (e.g., acute myocardial infarction, uncontrolled hypertension, decompensated heart failure, immunosuppression, systemic corticosteroid therapy, severe chronic obstructive pulmonary disease, chronic kidney disease stage 4-5), type 1 or type 2 diabetes mellitus, or psychiatric/neurological disorders impairing the ability to provide informed consent; * Tumor invasion into adjacent structures or organs (cT4b) identified preoperatively and/or intraoperatively; * Predicted risk of anastomotic leakage \>10% (AFOR 2-6).

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