Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy (LIVELOC)

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

Status: Completed

Conditions: Neoplasms; Ostomy; Rectal Neoplasms

Treatments: Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy; Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05745909

IK-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Loop transverse colostomy

Active Comparator group

Description:

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

Treatment:

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

Loop ileostomy

Experimental group

Description:

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

Treatment:

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