Low anterior resection with or without a preventive diverting stoma for low-risk rectal cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter randomized non-inferiority trial enrolling adults with mid- or low-rectal adenocarcinoma who have a predicted anastomotic leak risk of 10% or less. After consent, patients are randomized 1:1 to undergo minimally invasive total mesorectal excision with or without a diverting stoma, using stratified block randomization by center and sex. The primary outcome is anastomotic leakage within 30 days, with secondary outcomes including stoma status at 1 year, quality of life measures, short-term postoperative metrics, and reoperation rates; follow-up continues for one year. Cross-over to stoma formation during surgery is allowed for intraoperative safety concerns and complications are graded using Clavien-Dindo criteria.

Why it matters

Who can join: the full rules

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).

Where it's running

• Moscow City Oncology Hospital No. 62 of the Moscow Department of Health
  Moscow, Russia Recruiting
• Central Clinical Hospital of the Administrative Directorate of the President of the Russian Federation
  Moscow, Russia Recruiting
• 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 Recruiting
• State Autonomous Healthcare Institution of Nizhny Novgorod Region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncology Dispensary""
  Nizhny Novgorod, Russia Recruiting
• Leningrad Regional Clinical Hospital
  Saint Petersburg, Russia Recruiting
• Republican clinical oncological center
  Ufa, Russia Recruiting

Study contacts

• Study coordinator: Vladislava S Goncharova, Ms.
• Email: vladislava.26@mail.ru
• Phone: +7 900 468 9026

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.