Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy

Not Applicable

Active, not recruiting

• Conditions: Rectal Neoplasms; Ostomy; Neoplasms
• Interventions: Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy; Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy

• Registration Number: NCT05745909
• Lead Sponsor: Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan

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.

Study Timeline

• Study First Submitted: 2023-02-04
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-02-27
• Study Start: 2023-03-01
• Primary Completion: 2024-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loop ileostomy	Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy	Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop ileostomy
Loop transverse colostomy	Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy	Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop transverse colostomy

Primary Outcome Measures

Name	Time	Method
SSI	60 days after surgery	incidence of stoma site infections
Ileus	60 days after surgery	incidence of stoma dysfunction

Secondary Outcome Measures

Name	Time	Method
Time to adjuvant postoperative chemotherapy	within the first 2 months days after surgery	the number of days from surgery to hospitalization for first chemotherapy
Readmission rate	within the first 60 days after surgery	readmission rate
Length of hospital stay	From date of surgery until the date of discharge, assessed up to 60 days	the number of days from surgery to discharge
Quality of life in patients with ostomy	within the first 60 days after surgery	estimated using EORTC QLQ-CR29
Time to first stool	60 days after surgery	the occurrence of anything other than serous-hemorrhagic contents in the colostomy bag
Time to stoma closure	within the first 6 months days after surgery	the number of days from surgery to stoma closure

Trial Locations

Locations (1)

Republican clinical oncological dispencery; 🇷🇺 Ufa, Republic Of Bashkortostan, Russian Federation