LIVELOC: Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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.
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| 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
Primary Outcome Measures
- SSI [60 days after surgery]
incidence of stoma site infections
- Ileus [60 days after surgery]
incidence of stoma dysfunction
Secondary Outcome Measures
- Readmission rate [within the first 60 days after surgery]
readmission rate
- Length of hospital stay [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 [within the first 6 months days after surgery]
the number of days from surgery to stoma closure
- Time to first stool [60 days after surgery]
the occurrence of anything other than serous-hemorrhagic contents in the colostomy bag
- Time to adjuvant postoperative chemotherapy [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 [within the first 60 days after surgery]
estimated using EORTC QLQ-CR29
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed adenocarcinoma of the rectum (stages 1-3 according to MRI)
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ECOG status 0-2,
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ASA≤3.
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At least 18 years of age
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Written informed consent
Exclusion Criteria:
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Emergency surgery;
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Previously formed stoma;
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Stage 4 disease;
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Obstructive resection of the rectum;
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Patients older than 79 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Republican clinical oncological dispencery | Ufa | Republic Of Bashkortostan | Russian Federation | 450054 |
Sponsors and Collaborators
- Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IK-001