Rectal CancerSTOMALEFTNCT06149741
Defunctioning Left-sided Colostomy in Low Anterior Resection for Rectal Cancer
A study testing Defunctioning left-sided loop colostomy in people with Rectal Cancer, run by Umeå University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Defunctioning left-sided loop colostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- 20 Nov 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Capacity for informed consent
- Planned defunctioning stoma
- Planned mesorectal excision with anastomosis for rectal cancer
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Defunctioning left-sided loop colostomy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defunctioning left-sided loop colostomyProcedure or surgery
Descending or left transverse double-barrelled loop colostomy in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision, and anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Left-sided loop colostomy | Experimental | Left-sided loop colostomy matured in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision and anastomosis Receives: Procedure: Defunctioning left-sided loop colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low anterior resection syndrome (LARS)
Rate of major LARS (score 31-42) as measured by the LARS questionnaire, which assesses bowel dysfunction.
Measured: 1 year
Secondary outcomes (1)
Bowel ischaemia
Rate of ischaemia/necrosis of the colonic limb due to marginal artery compromise.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start20 Nov 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2025
Why it stopped: Logistical difficulties at study sites. 16/20 patients included.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Sunderby Hospital, Östersunds Hospital, Sundsvall Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149741
- Sponsor's protocol ID
- UmU-STOMALEFT
- Acronym
- STOMALEFT
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defunctioning Left-sided Colostomy in Low Anterior Resection for Rectal Cancer
- ClinicalTrials.gov ID
- NCT06149741
- Acronym / sponsor ID
- STOMALEFT / UmU-STOMALEFT
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistical difficulties at study sites. 16/20 patients included.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Sunderby Hospital, Östersunds Hospital, Sundsvall Hospital
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left-sided loop colostomy | Experimental | Procedure: Defunctioning left-sided loop colostomyLeft-sided loop colostomy matured in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision and anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Capacity for informed consent
- Planned defunctioning stoma
- Planned mesorectal excision with anastomosis for rectal cancer
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Defunctioning left-sided loop colostomyDescending or left transverse double-barrelled loop colostomy in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision, and anastomosis. | Procedure or surgery | Left-sided loop colostomy |
Primary outcome
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 secondary outcome
Bowel ischaemia
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Logistical difficulties at study sites. 16/20 patients included.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defunctioning left-sided loop colostomy in people with Rectal Cancer, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Logistical difficulties at study sites. 16/20 patients included.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low anterior resection syndrome (LARS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.