NCT07463261

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
442

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started May 2026

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
May 2026Jun 2027

First Submitted

Initial submission to the registry

February 25, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 5, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2027

Last Updated

May 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

February 25, 2026

Last Update Submit

May 11, 2026

Conditions

TMERectal Cancer SurgeryLow Rectal CancerMiddle Rectal CancerLocal Advanced Rectal Cancer

Keywords

rectal cancerpreventive stomarandomized triallow-risk patientsanastomotic leak

Outcome Measures

Primary Outcomes (1)

  • Colorectal anastomotic leak

    If anastomotic leakage is suspected in the postoperative period defined by worsening abdominal pain (\>5-point increase on the Visual Analog Scale), signs of peritonitis, drain output containing fibrin or intestinal content, or radiologic findings suggestive of leakage on contrast-enhanced CT of the abdomen and pelvis (with or without proctography) and/or findings at diagnostic laparoscopy. Diagnostic and/or therapeutic measures will be undertaken to confirm or rule out the complication.

    30 days after main surgery

Secondary Outcomes (8)

  • Postoperative complications

    30 days after main surgery

  • Reoperation rate

    30 days and 1 year after main surgery

  • Stoma rate

    1 year after main surgery

  • Hospital readmissions

    30 days after main surgery

  • Quality of life by European Organization for Research and Treatment of Cancer-Cancer30 (EORTC-C30)

    30 days and 1 year after surgery

  • +3 more secondary outcomes

Study Arms (2)

Without a preventive stoma

EXPERIMENTAL

In the no-stoma group, a diverting stoma will not be created provided there are no intraoperative complications and surgical safety principles are maintained. If intraoperative findings suggest a high risk of anastomotic leakage such as a positive air leak test of the colorectal anastomosis, bowel perforation, use of three or more linear stapler cartridges, blood loss \>300 mL, impaired bowel wall perfusion, or tension at the anastomotic site and/or if patient safety is deemed at risk, a diverting stoma may be created at the surgeon's discretion (cross-over).

Procedure: Without a preventive stoma

With a preventive stoma

ACTIVE COMPARATOR

In the stoma group, a diverting ileostomy or colostomy will be created at the end of the surgical procedure in the right or left lateral abdominal wall, according to the technique routinely used at each participating center. Stoma closure will be planned according to standard practice (no earlier than 2-3 months after surgery), provided there are no contraindications.

Procedure: With a preventive stoma

Interventions

Without a preventive stomaPROCEDURE

At the conclusion of total mesorectal excision (TME), a diverting ileostomy or transverse colostomy will be created at the discretion of the operating surgeon. The pelvic peritoneum over the anastomotic site will be closed, and a pelvic drain will be placed (the type of drain will be determined by the operating surgeon).

Without a preventive stoma
With a preventive stomaPROCEDURE

The operating surgeon will follow the standard practice adopted at the respective center and will create either a diverting ileostomy or transverse colostomy at their discretion. The pelvic peritoneum will not be closed. Placement of a percutaneous pelvic drain adjacent to the anastomotic site is mandatory.

With a preventive stoma

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Moscow City Oncology Hospital No. 62 of the Moscow Department of Health

Moscow, 143423, 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

MeSH Terms

Conditions

Rectal NeoplasmsAnastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Vladislava S Goncharova, Ms.

CONTACT

+7 900 468 9026vladislava.26@mail.ru

Nikita N Burlov, Dr.

CONTACT

+79819430019dikefsound@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 11, 2026

Study Start

May 5, 2026

Primary Completion (Estimated)

June 10, 2027

Study Completion (Estimated)

June 10, 2027

Last Updated

May 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(7)