Comparing two approaches for treating acute colon cancer obstruction
Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma: a Prospective Cohort Study
Skane University Hospital · NCT04450758
This study is testing whether a two-step treatment for colon cancer obstruction, which involves using a stent or stoma, works better than immediate surgery in helping patients recover and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Skane University Hospital (other) |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT04450758 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the outcomes of primary resection versus a two-stage approach involving decompression with a stent or stoma for patients with malignant obstruction of the colon. The study will assess postoperative morbidity and mortality within 30 days, as well as long-term survival rates at 3 and 5 years. By comparing these two interventions, the researchers hope to determine if the two-stage procedure can lead to better short-term and long-term outcomes for patients. The study will include patients who are symptomatic and have CT-verified colon obstruction due to cancer.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with symptomatic large bowel obstruction due to colon cancer requiring acute intervention.
Not a fit: Patients with colonic perforation, bleeding, or obstruction from causes other than colon cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and survival rates for patients with acute colon cancer obstruction.
How similar studies have performed: Previous studies have shown promising results with similar two-stage approaches in managing malignant bowel obstructions, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Symptomatic large bowel obstruction requiring acute intervention * CT-verified colon obstruction due to colon cancer independent of presence of metastases * Informed consent Exclusion Criteria: * Colonic perforation or bleeding * Colonic obstruction of other origin than colon cancer * Palliative situation
Where this trial is running
Gothenburg
- Göteborg University — Gothenburg, Sweden (RECRUITING)
Study contacts
- Principal investigator: Pamela Buchwald, PhD MD — Skåne University Hospital, Lund University
- Study coordinator: Pamela Buchwald, PhD MD
- Email: pamela.buchwald@med.lu.se
- Phone: 004640331000
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.
Conditions: Colon Cancer