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

May 4, 2026 updated by: Umeå University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, 90187
        • Umea University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Left-sided loop colostomy
Left-sided loop colostomy matured in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision and anastomosis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low anterior resection syndrome (LARS)
Time Frame: 1 year
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
Time Frame: 30 days
Rate of ischaemia/necrosis of the colonic limb due to marginal artery compromise.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

Sundsvall Hospital
Sunderby Hospital
Östersund Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UmU-STOMALEFT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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