Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy (LIVELOC)

• ClinicalTrials.gov Identifier: NCT05745909
• Recruitment Status: Recruiting
• First Posted: February 27, 2023
• Last Update Posted: April 29, 2024
• Sponsor: Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
• Information provided by (Responsible Party): Maksim Popov, Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan

Tracking Information

• First Submitted Date: February 4, 2023
• First Posted Date: February 27, 2023
• Last Update Posted Date: April 29, 2024
• Actual Study Start Date: March 1, 2023
• Estimated Primary Completion Date: May 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 23, 2023)

• SSI [ Time Frame: 60 days after surgery ]
  incidence of stoma site infections
• Ileus [ Time Frame: 60 days after surgery ]
  incidence of stoma dysfunction

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 23, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Rectal Neoplasms
• Ostomy
• 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.
• 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.

Study Arms

• Active Comparator: Loop transverse colostomy
  Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop transverse colostomy
  Intervention: Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy
• Experimental: Loop ileostomy
  Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop ileostomy
  Intervention: Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 23, 2023): 130
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 30, 2024
• Estimated Primary Completion Date: May 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Rustem Aupov; +79173448501; ru2003@bk.ru

• Listed Location Countries: Russian Federation

Administrative Information

• NCT Number: NCT05745909
• Other Study ID Numbers: IK-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Maksim Popov, Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
• Original Responsible Party: Same as current
• Current Study Sponsor: Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
• Verification Date: April 2024