Actively Recruiting
A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm) - a Randomized Controlled Trial (COLDSNAP-2)
Led by Technical University of Munich · Updated on 2024-11-12
850
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Colorectal cancer is one of the most common and deadly cancers worldwide, with adenomatous polyps in the colon as possible precursors. Screening and removal of these polyps, especially by colonoscopy, can help prevent colorectal cancer and related deaths. This trial aims to compare two polyp removal techniques, hot snare polypectomy (HSP) and cold snare polypectomy (CSP), for polyps sized 10 to 15 mm to evaluate their complete removal rates and safety. Participants with eligible polyps will be randomly assigned to have their polyps removed either by HSP, which uses electrocautery, or CSP, which removes polyps without electrocautery. After removal, the site is thoroughly washed and examined for any remaining polyp tissue, with additional removal if needed. Four biopsies are taken from the edges of the removal site to check for leftover abnormal tissue. Throughout the study, researchers will monitor complete polyp removal rates over six months. They will also assess immediate bleeding during the procedure, difficulty of removal with CSP, time taken for removal, and any procedure-related adverse events. The study is sponsored by the Technical University of Munich and involves regular evaluations to ensure participant safety and treatment effectiveness.
CONDITIONS
Brief Title
A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for colonoscopy
- At least 1 adenomatous polyp 10-15 mm
- Provided written informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo colonoscopy to identify eligible polyps and receive polypectomy using either Hot Snare Polypectomy or Cold Snare Polypectomy according to randomization. After polypectomy, the resection site is examined and biopsied to check for residual neoplastic tissue.
1 procedure visit (in-person)
Duration - 6 months
Participants are monitored for procedure-related adverse events and evaluated for complete resection rate over 6 months following the polypectomy.
Follow-up visits as needed
Trial Site Locations
Total: 1 location
1
Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technische Universität München
München, Bavaria, Germany, 81675
Actively Recruiting
Research Team
V
Veit Phillip, MD
J
Joerg Ulrich, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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