New approach to colostomy for rectal cancer surgery
Defunctioning Left-sided Colostomy in Low Anterior Resection for Rectal Cancer
This study is testing a new type of colostomy surgery for rectal cancer to see if it can help patients have fewer complications and better bowel function after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 1 site (Umeå) |
| Trial ID | NCT06149741 on ClinicalTrials.gov |
What this trial studies
This prospective, multi-center study evaluates a novel type of defunctioning loop stoma following low anterior resection for rectal cancer. The procedure involves complete splenic flexure mobilization and total mesorectal excision, with an anastomosis created at the pelvic floor. A redundant colon will be brought up and matured in the left iliac fossa, and patient bowel function and quality of life will be monitored at baseline and one year postoperatively. The study aims to reduce complications such as dehydration and kidney injury compared to traditional loop ileostomy, with approximately 20 patients participating in this pilot study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require a defunctioning stoma and are undergoing mesorectal excision for rectal cancer.
Not a fit: Patients with significant atherosclerotic disease or previous oncological colonic resections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved bowel function and quality of life for patients undergoing rectal cancer surgery.
How similar studies have performed: While this approach is novel, similar studies have shown promise in improving outcomes for patients undergoing colorectal surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Umeå
- Umeå University Hospital — Umeå, Sweden (Recruiting)
Study contacts
- Study coordinator: Martin Rutegård, MD, PhD
- Email: martin.rutegard@umu.se
- Phone: +46907850000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.