Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy

Neoplasms Clinical Trial

— LIVELOC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05745909
• Other study ID #: IK-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: June 2024
• Source: Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: July 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Ostomy
• Rectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Republican clinical oncological dispencery	Ufa	Republic Of Bashkortostan

Sponsors (1)

Lead Sponsor	Collaborator
Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SSI	incidence of stoma site infections	60 days after surgery
Primary	Ileus	incidence of stoma dysfunction	60 days after surgery
Secondary	Readmission rate	readmission rate	within the first 60 days after surgery
Secondary	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
Secondary	Time to stoma closure	the number of days from surgery to stoma closure	within the first 6 months days after surgery
Secondary	Time to first stool	the occurrence of anything other than serous-hemorrhagic contents in the colostomy bag	60 days after surgery
Secondary	Time to adjuvant postoperative chemotherapy	the number of days from surgery to hospitalization for first chemotherapy	within the first 2 months days after surgery
Secondary	Quality of life in patients with ostomy	estimated using EORTC QLQ-CR29	within the first 60 days after surgery