NCT05745909

Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy

Randomized Single Center Clinical Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy in Patients After Major Anterior Resections

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-05-31
• Completion: 2024-07-30
• First posted: 2023-02-27
• Last updated: 2024-09-19

Locations

1 site across 1 country: Russia