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Trial Title:
Defunctioning Left-sided Colostomy in Low Anterior Resection for Rectal Cancer
NCT ID:
NCT06149741
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Defunctioning left-sided loop colostomy
Description:
Descending or left transverse double-barrelled loop colostomy in left iliac fossa after
complete splenic flexure mobilisation, mesorectal excision, and anastomosis.
Arm group label:
Left-sided loop colostomy
Summary:
This is prospective, multi centre study evaluating a novel type of defunctioning loop
stoma after low anterior resection for rectal cancer. Patients will be operated with a
complete splenic flexure mobilisation and total mesorectal excision. An anastomosis will
be fashioned at the pelvic floor. This will leave a redundant colon which will be brought
up and matured in the left iliac fossa. Patient bowel function and quality of life will
be monitored at baseline and at one year postoperatively, when the stoma will typically
have been reversed. Dehydration and kidney injury are expected to become infrequent in
comparison with the main alternative loop ileostomy. About 20 patients will be included
in this pilot study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥18 years
- Capacity for informed consent
- Planned defunctioning stoma
- Planned mesorectal excision with anastomosis for rectal cancer
Exclusion Criteria:
- Manifest atherosclerotic disease (peripheral vascular disease, previous myocardial
infarction, angina, etc)
- Previous oncological colonic resection
- Defunctioning stoma in situ
- Intraoperative event leading to bowel resection and subsequent inability to bring
out left-sided colostomy without tension on the anastomosis
- Intraoperative circumstances as judged by the operating surgeon leading to
unacceptable risks due to loop colostomy placement (abdominal wall size, short
mesentery, other preconditions)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Umeå University Hospital
Address:
City:
Umeå
Zip:
90187
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Martin Rutegård, MD, PhD
Email:
martin.rutegard@umu.se
Start date:
November 20, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Umeå University
Agency class:
Other
Collaborator:
Agency:
Sunderby Hospital
Agency class:
Other
Collaborator:
Agency:
Östersund Hospital
Agency class:
Other
Collaborator:
Agency:
Sundsvall Hospital
Agency class:
Other
Source:
Umeå University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06149741
