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

U

Umeå University

Status

Enrolling

Conditions

Rectal Cancer

Treatments

Procedure: Defunctioning left-sided loop colostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06149741
UmU-STOMALEFT

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Left-sided loop colostomy
Experimental group
Description:
Left-sided loop colostomy matured in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision and anastomosis
Treatment:
Procedure: Defunctioning left-sided loop colostomy

Trial contacts and locations

1

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Central trial contact

Martin Rutegård, MD, PhD

Data sourced from clinicaltrials.gov

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