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

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06149741

Acronym

STOMALEFT

Enrollment

Registered

2023-11-29

Start date

2023-11-20

Completion date

2025-07-31

Last updated

2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

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.

Interventions

PROCEDUREDefunctioning 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Low anterior resection syndrome (LARS)	1 year	Rate of major LARS (score 31-42) as measured by the LARS questionnaire, which assesses bowel dysfunction.

Secondary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026