MedTrace Logo

REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department

NCT07463261 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • TME
  • Rectal Cancer Surgery
  • Low Rectal Cancer
  • Middle Rectal Cancer
  • Local Advanced Rectal Cancer

Interventions

PROCEDURE

Without a preventive stoma

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).

PROCEDURE

With a preventive stoma

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.

Sponsors & Collaborators

  • ANO Scientific and Practical Club for the Development of Modern Medical Technologies

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-05
Primary Completion
2027-06-10
Completion
2027-06-10

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07463261 on ClinicalTrials.gov