Defunctioning Left-sided Colostomy in Low Anterior Resection for Rectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Defunctioning Left-sided Colostomy in Low Anterior Resection for Rectal Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Defunctioning left-sided loop colostomy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left-sided loop colostomy<br>Left-sided loop colostomy matured in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision and anastomosis | Procedure: Defunctioning left-sided loop colostomy<br>* Descending or left transverse double-barrelled loop colostomy in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision, and anastomosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low anterior resection syndrome (LARS) | Rate of major LARS (score 31-42) as measured by the LARS questionnaire, which assesses bowel dysfunction. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel ischaemia | Rate of ischaemia/necrosis of the colonic limb due to marginal artery compromise. | 30 days |