Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy (LIVELOC)

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

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

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Rectal Neoplasms; Ostomy
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rustem Aupov; Phone Number: +79173448501; Email: ru2003@bk.ru

Study Locations

• Russian Federation
  • Republic Of Bashkortostan
    • Ufa, Republic Of Bashkortostan, Russian Federation, 450054
      • Recruiting
      • Republican clinical oncological dispencery
      • Contact: Rustem Aupov; Phone Number: +79173448501; Email: ru2003@bk.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Loop transverse colostomy; Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop transverse colostomy	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.
Experimental: Loop ileostomy; Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop ileostomy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SSI	incidence of stoma site infections	60 days after surgery
Ileus	incidence of stoma dysfunction	60 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: February 4, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Rectal cancer; Low anterior resection; Loop ileostomy; Loop transverse colostomy; Stoma site infections
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: IK-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No