Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy

NCT05745909 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-09-19

No results posted yet for this study

Summary

The purpose of this study is to determine which stoma creation technique is preferable after low anterior resection of the rectum.

Conditions

  • Rectal Neoplasms
  • Ostomy
  • Neoplasms

Interventions

PROCEDURE

Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy

The loop transverse colostomy is matured without torsion using a plastic retainer. The stoma protrudes 2-3 cm. The loop of the transverse colon is sutured with interrupted sutures using an absorbable 3/0 polyglactin suture without piercing the intestinal wall. The intestinal lumen is opened through a transverse incision on the antimesenteric border.

PROCEDURE

Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy

The loop ileostomy is matured 25-30 cm from the ileocecal angle without torsion and without a retainer, so that stoma protrudes 2-3 cm. The loop of the ileum is sutured with interrupted sutures using an absorbable 3/0 polyglactin suture without piercing the intestinal wall. The intestinal lumen is opened through a transverse incision on the antimesenteric border.

Sponsors & Collaborators

  • Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-05-31
Completion
2024-07-30

Countries

  • Russia

Study Locations

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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 NCT05745909 on ClinicalTrials.gov