Actively Recruiting
REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department
Led by ANO Scientific and Practical Club for the Development of Modern Medical Technologies · Updated on 2026-05-13
442
Participants Needed
7
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 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 or less from the dentate line
- Planned radical minimally invasive total mesorectal excision with primary colorectal or colon-anal anastomosis
- Adequate blood function: hemoglobin 100 g/L or higher, leukocytes over 4 x 10^9/L, platelets over 100 x 10^9/L
- Adequate kidney function: serum creatinine less than 150 µmol/L
- Adequate liver function: AST and ALT less than 100 U/L
- Predicted risk of anastomotic leakage 10% or less (AFOR 0-1)
You will not qualify if you...
- Age 80 years or older
- Presence of an existing diverting ileostomy or colostomy
- Peritumoral abscess or tumor perforation
- Distant metastases (M1) found before or during surgery
- Having another cancer occurring at the same or different time
- Prior pelvic radiation for another disease such as cervical or prostate cancer
- Evidence of malnutrition with serum albumin less than 34 g/L
- Severe uncontrolled medical conditions like heart attack, uncontrolled high blood pressure, heart failure, immune suppression, steroid therapy, severe lung disease, advanced kidney disease, diabetes, or mental disorders affecting consent ability
- Tumor invading nearby organs or structures (cT4b) before or during surgery
- Predicted risk of anastomotic leakage greater than 10% (AFOR 2-6)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Moscow City Oncology Hospital No. 62 of the Moscow Department of Health
Moscow, Russia, 143423
Actively Recruiting
2
Central Clinical Hospital of the Administrative Directorate of the President of the Russian Federation
Moscow, Russia
Actively Recruiting
3
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
Actively Recruiting
4
State Autonomous Healthcare Institution of Nizhny Novgorod Region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncology Dispensary""
Nizhny Novgorod, Russia
Actively Recruiting
5
Leningrad Regional Clinical Hospital
Saint Petersburg, Russia
Actively Recruiting
6
Republican clinical oncological center
Ufa, Russia
Actively Recruiting
7
Sverdlovsk Regional Oncological Center
Yekaterinburg, Russia
Actively Recruiting
Research Team
V
Vladislava S Goncharova, Ms.
CONTACT
N
Nikita N Burlov, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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