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

RecruitingNAAges 18 Years - 70 YearsAllANO Scientific and Practical Club for the Develop…
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In plain words

What the trial is, and whether it could suit you

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-

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

  • Without a preventive stoma
  • With a preventive stoma
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Where

7 sites
Moscow City Oncology Hospital No. 62 of the Moscow Department of Health
Moscow, Russia
Central Clinical Hospital of the Administrative Directorate of the President of the Russian Federation
Moscow, Russia
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
State Autonomous Healthcare Institution of Nizhny Novgorod Region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncology Dispensary""
Nizhny Novgorod, Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, Russia
Republican clinical oncological center
Ufa, Russia
Sverdlovsk Regional Oncological Center
Yekaterinburg, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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