Clinical trial · Interventional
Defunctioning Left-sided Colostomy in Low Anterior Resection for Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Logistical difficulties at study sites. 16/20 patients included.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Defunctioning left-sided loop colostomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Left-sided loop colostomy
- description
- Left-sided loop colostomy matured in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision and anastomosis
- interventionNames
- Procedure: Defunctioning left-sided loop colostomy
Primary outcomes (1)
- measure
- Low anterior resection syndrome (LARS)
- timeFrame
- 1 year
- description
- Rate of major LARS (score 31-42) as measured by the LARS questionnaire, which assesses bowel dysfunction.
Secondary outcomes (1)
- measure
- Bowel ischaemia
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available