REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department
Recruiting now · Not applicable
Conditions studied: TME, Rectal Cancer Surgery, Low Rectal Cancer, Middle Rectal Cancer, Local Advanced Rectal Cancer
In brief
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.
Key facts
- Study ID
- NCT07463261
- Run by
- ANO Scientific and Practical Club for the Development of Modern Medical Technologies
- People needed
- 442
- Starts
- 2026-05-05
- Expected to finish
- 2027-06-10
- Last updated by the study team
- 2026-05-13
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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).
Where it is running
- Moscow City Oncology Hospital No. 62 of the Moscow Department of Health — Moscow, Russia (enrolling)
- Central Clinical Hospital of the Administrative Directorate of the President of the Russian Federation — Moscow, Russia (enrolling)
- State Budgetary Institution of Healthcare of the city of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Healthcare of the City of Moscow" — Moscow, Russia (enrolling)
- State Autonomous Healthcare Institution of Nizhny Novgorod Region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncology Dispensary"" — Nizhny Novgorod, Russia (enrolling)
- Leningrad Regional Clinical Hospital — Saint Petersburg, Russia (enrolling)
- Republican clinical oncological center — Ufa, Russia (enrolling)
- Sverdlovsk Regional Oncological Center — Yekaterinburg, Russia (enrolling)
Full record on ClinicalTrials.gov
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