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

Rectal Cancer Clinical Trial

— STOMALEFT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149741
• Other study ID #: UmU-STOMALEFT
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Umeå University
• Contact: Martin Rutegård, MD, PhD
• Phone: +46907850000
• Email: martin.rutegard[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Defunctioning left-sided loop colostomy
Descending or left transverse double-barrelled loop colostomy in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision, and anastomosis.

Locations

Country	Name	City	State
Sweden	Umeå University Hospital	Umeå

Sponsors (4)

Lead Sponsor	Collaborator
Umeå University	Östersund Hospital, Sunderby Hospital, Sundsvall Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bowel ischaemia	Rate of ischaemia/necrosis of the colonic limb due to marginal artery compromise.	30 days