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

Not Applicable

Recruiting

• Conditions: Rectal Cancer
• Interventions: Procedure: Defunctioning left-sided loop colostomy

• Registration Number: NCT06149741
• Lead Sponsor: Umeå University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-20
• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-11
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Left-sided loop colostomy	Defunctioning left-sided loop colostomy	Left-sided loop colostomy matured in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision and anastomosis

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Bowel ischaemia	30 days	Rate of ischaemia/necrosis of the colonic limb due to marginal artery compromise.

Trial Locations

Locations (1)

Umeå University Hospital; 🇸🇪 Umeå, Sweden