A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Comparator: Hot Snare Polypectomy, Experimental: Cold Snare Polypectomy.
- Who it may be relevant to
- Registry conditions: Adenomatous Polyps. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm) - a Randomized Controlled Trial (COLDSNAP-2)
Overview
Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 19 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps \<5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen. In this randomized controlled trial, the investigators want to compare the complete resection rates of small and intermediate sized colorectal polyps 10-15 mm with CSP and HSP.
Interventions
- Procedure Active Comparator: Hot Snare Polypectomy
Hot Snare Polypectomy with the use of electrocautery for the resection of polyps. - Procedure Experimental: Cold Snare Polypectomy
Cold Snare Polypectomy without the use of electrocautery for the resection of polyps.
Primary outcome measures
- Complete resection rate [Time frame: 6 months]
Secondary outcome measures (5)
- En-bloc resection rate [Time frame: During procedure]
- Rate of immediate bleeding with necessity of haemostasis [Time frame: During procedure]
- Rate of impossible resection by CSP [Time frame: During procedure]
- Time required for resection [Time frame: During procedure]
- Rate of procedure-related adverse events. [Time frame: 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Germany · 1 center
- Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technische Universi — München
Identifiers
NCT: NCT04816292 · 2021-90-S-P