Comparing hot and cold methods for removing colorectal polyps
A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm) - a Randomized Controlled Trial (COLDSNAP-2)
This study is testing whether using hot or cold methods to remove certain types of polyps during a colonoscopy is safer and more effective for patients who need this procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 850 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 1 site (München, Bavaria) |
| Trial ID | NCT04816292 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness and safety of hot snare polypectomy (HSP) and cold snare polypectomy (CSP) in removing adenomatous polyps sized 10-15 mm during colonoscopy. HSP uses electrocautery, which can lead to adverse events, while CSP is gaining popularity for its ease and reduced complications. The study will enroll patients who require colonoscopy and have at least one adenomatous polyp within the specified size range. Participants will be randomly assigned to receive either HSP or CSP, and outcomes will be measured to determine the resection rates and safety profiles of both techniques.
Who should consider this trial
Good fit: Ideal candidates include individuals scheduled for colonoscopy with at least one adenomatous polyp measuring 10-15 mm.
Not a fit: Patients with severe comorbidities, inflammatory bowel disease, or those requiring emergency colonoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective methods for polyp removal, potentially reducing the risk of colorectal cancer.
How similar studies have performed: Previous studies have shown promising results for cold snare polypectomy, indicating its potential advantages over traditional methods, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Indication for colonoscopy * at least 1 adenomatous polyp 10-15 mm * provided written informed consent Exclusion Criteria: * American Society of Anaesthesiologists class IV or higher * florid inflammatory bowel disease * emergency indication for colonoscopy * haemorrhagic diathesis * continued dual antiplatelet therapy * continued anticoagulant therapy
Where this trial is running
München, Bavaria
- Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technische Universität München — München, Bavaria, Germany (Recruiting)
Study contacts
- Study coordinator: Veit Phillip, MD
- Email: veit.phillip@mri.tum.de
- Phone: +49894140
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.