Rectal cancer surgery with or without a temporary stoma in lower-risk patients
Compares rectal cancer surgery with and without a temporary stoma in adults.
Plain-language title generated from the registry record
Registry title: REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department
Key facts
- Where
- Moscow, Nizhny Novgorod, Saint Petersburg, Ufa, and Yekaterinburg, RussiaSee the 7 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07463261, who can take part
Where in Russia
- Central Clinical Hospital of the Administrative Directorate of the President of the Russian FederationMoscow, RussiaTaking people
- Moscow City Oncology Hospital No. 62 of the Moscow Department of HealthMoscow, RussiaTaking people
- 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, RussiaTaking people
- State Autonomous Healthcare Institution of Nizhny Novgorod Region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncology Dispensary""Nizhny Novgorod, RussiaTaking people
- Leningrad regional clinical hospitalSaint Petersburg, RussiaTaking people
- Republican clinical oncological centerUfa, RussiaTaking people
- Sverdlovsk Regional Oncological CenterYekaterinburg, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ANO Scientific and Practical Club for the Development of Modern Medical Technologies
- Trial code
- NCT07463261
- Record updated
- 13 May 2026
- Original description
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.Read full original descriptionShow less
Results of Anastomotic Leak After Low Anterior Resection With or Without Preventive Stoma for Rectal Cancer in Low-risk Patients in Nonemergency Departments (RELOAD): Protocol of Multicenter Randomized Controlled Non-inferiority Trial
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.
Inclusion: 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: Prior pelvic irradiation for another condition (e.g., cervical or prostate cancer); Peritumoral abscess or tumor perforation; Synchronous or metachronous malignancy; 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; Evidence of malnutrition (serum albumin <34 g/L); Age ≥80 years; Presence of a pre-existing diverting ileostomy or colostomy; Distant metastases (M1) identified preoperatively and/or intraoperatively; Tumor invasion into adjacent structures or organs (cT4b) identified preoperatively and/or intraoperatively; Predicted risk of anastomotic leakage >10% (AFOR 2-6).