Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy

NCT ID: NCT05745909

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-07-30

Brief Summary

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

Detailed Description

The investigators enroll patients with a histologically confirmed diagnosis of primary rectal cancer with or without prior chemoradiotherapy who were hospitalized at the Ufa Republican Clinical Oncology Center from February 2023 to February 2024.

All patients undergo planned laparoscopic or open low-anterior resection of the rectum with total mesorectal excision. Patients are randomized into 2 groups in a 1:1 ratio. In the first group, a loop transverse colostomy is created, and in the second group, a loop ileostomy is created. The stoma exit sites are marked in advance the day before the surgery. The bowels are prepared by mechanical means (a polyethylene glycol-based laxative with a cleansing enema) according to a standard procedure before the surgery. Standardized stoma creation techniques are used. The resected parts are collected through a separate access. Patients are followed up for 60 days after surgery.

The sample size should be 124 patients to reach statistical significance (α = 0.05, study power 80%, confidence interval (CI) = 95%.). Considering possible losses during the study, the number of patients was increased to 130.

The investigators hypothesis is that the loop ileostomy group has a 20% higher incidence of stoma dysfunction but a 20% lower incidence of SSI (stoma site infections) compared to the loop colostomy group.

Conditions

Rectal Neoplasms; Ostomy; Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Loop transverse colostomy

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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.

Loop ileostomy

Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop ileostomy

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed adenocarcinoma of the rectum (stages 1-3 according to MRI)
• ECOG status 0-2,
• ASA≤3.
• At least 18 years of age
• Written informed consent

Exclusion Criteria

• Emergency surgery;
• Previously formed stoma;
• Stage 4 disease;
• Obstructive resection of the rectum;
• Patients older than 79 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Maksim Popov

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Republican clinical oncological dispencery

Ufa, Bashkortostan Republic, Russia

Countries

Russia

Other Identifiers

IK-001

Identifier Type: -

Identifier Source: org_study_id