NCT07463261Recruiting
REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department
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
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 442 (estimated)
- First submitted
- 25 Feb 2026
- Start date
- 5 May 2026
- Primary completion date
- 10 Jun 2027
- Lead sponsor
- ANO Scientific and Practical Club for the Development of Modern Medical Technologies
- Diseases
- Colorectal cancer
- NCT number
- NCT07463261
What you commit to
- Study type: Interventional
- Planned participants: 442
- From 5 May 2026 to the primary completion date, 10 Jun 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic irradiation for another condition (e.g., cervical or prostate cancer);
Other illness
- 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;
Lab values
- Evidence of malnutrition (serum albumin \<34 g/L);
Age
- Age ≥80 years;
Other
- 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).
Who the study is looking for
- 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).
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 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" Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| Central Clinical Hospital of the Administrative Directorate of the President of the Russian Federation Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| Moscow City Oncology Hospital No. 62 of the Moscow Department of Health Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| State Autonomous Healthcare Institution of Nizhny Novgorod Region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncology Dispensary"" Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Recruiting |
| Leningrad regional clinical hospital Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
| Republican clinical oncological center Coordinator of this site? Confirm its status | Ufa | Russia | Recruiting |
| Sverdlovsk Regional Oncological Center Coordinator of this site? Confirm its status | Yekaterinburg | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.