Spots Global Cancer Trial Database for Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy

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Trial Identification

Brief Title: Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy

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

Study ID: NCT05745909

Conditions

Rectal Neoplasms

Ostomy

Neoplasms

Interventions

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 TME and created loop ileostomy

Study Description

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.