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

NCT06149741 | Unknown

• 1 other identifier: UmU-STOMALEFT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bowel ischaemia

  30 days

Study Arms (1)

Left-sided loop colostomy

EXPERIMENTAL

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

Procedure: Defunctioning left-sided loop colostomy

Interventions

Defunctioning left-sided loop colostomy PROCEDURE

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

Left-sided loop colostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Capacity for informed consent
• Planned defunctioning stoma
• Planned mesorectal excision with anastomosis for rectal cancer

You may not qualify if:

• 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)

Sponsors & Collaborators

• Umeå University: lead
• Sunderby Hospital: collaborator
• Östersund Hospital: collaborator
• Sundsvall Hospital: collaborator

Study Sites (1)

Umeå University Hospital

Umeå, 90187, Sweden

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Martin Rutegård, MD, PhD

CONTACT

+46907850000; martin.rutegard@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 29, 2023
• Study Start: November 20, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

SE (1)