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Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy (LIVELOC)

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

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

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Ostomy Neoplasms 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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Single Center Clinical Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy in Patients After Major Anterior Resections
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : July 30, 2024
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. SSI [ Time Frame: 60 days after surgery ]
    incidence of stoma site infections

  2. Ileus [ Time Frame: 60 days after surgery ]
    incidence of stoma dysfunction


Secondary Outcome Measures :
  1. Readmission rate [ Time Frame: within the first 60 days after surgery ]
    readmission rate

  2. 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

  3. Time to stoma closure [ Time Frame: within the first 6 months days after surgery ]
    the number of days from surgery to stoma closure

  4. Time to first stool [ Time Frame: 60 days after surgery ]
    the occurrence of anything other than serous-hemorrhagic contents in the colostomy bag

  5. 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

  6. Quality of life in patients with ostomy [ Time Frame: within the first 60 days after surgery ]
    estimated using EORTC QLQ-CR29


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05745909


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

Locations
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Russian Federation
Republican clinical oncological dispencery Recruiting
Ufa, Republic Of Bashkortostan, Russian Federation, 450054
Contact: Rustem Aupov    +79173448501    ru2003@bk.ru   
Sponsors and Collaborators
Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
More Information
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Responsible Party: Maksim Popov, Principal Investigator, Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
ClinicalTrials.gov Identifier: NCT05745909    
Other Study ID Numbers: IK-001
First Posted: February 27, 2023    Key Record Dates
Last Update Posted: April 29, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maksim Popov, Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan:
Rectal cancer
Low anterior resection
Loop transverse colostomy
Loop ileostomy
Stoma site infections
Additional relevant MeSH terms:
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Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases