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

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

This trial tests whether adults having minimally invasive total mesorectal excision for mid- or low-rectal cancer with a low predicted leak risk can safely avoid a temporary diverting stoma.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 442 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: ANO Scientific and Practical Club for the Development of Modern Medical Technologies (other)
• Locations: 7 sites (Moscow and 6 other locations)
• Trial ID: NCT07463261 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults under 80 with histologically confirmed mid- or low-rectal adenocarcinoma scheduled for minimally invasive TME and a predicted anastomotic leak risk of 10% or less are ideal candidates.

Not a fit: Patients with higher predicted leak risk, distant metastases, existing diverting stomas, emergency presentations, or other major contraindications are unlikely to benefit from omitting a preventive stoma.

Why it matters

Potential benefit: If successful, eligible patients could avoid a temporary stoma and its associated complications and impacts on quality of life.

How similar studies have performed: Prior observational studies and smaller randomized trials have suggested selective omission of diverting stomas can be safe in low-risk patients, but larger randomized multicenter data remain limited.

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).

Where this trial is running

Moscow and 6 other locations

• 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)
• Sverdlovsk Regional Oncological Center — Yekaterinburg, Russia (RECRUITING)

Study contacts

• Study coordinator: Vladislava S Goncharova, Ms.

Conditions: TME, Rectal Cancer Surgery, Low Rectal Cancer, Middle Rectal Cancer, Local Advanced Rectal Cancer, rectal cancer, preventive stoma, randomized trial