RecruitingNot ApplicableNCT04816292

A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm)

A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm) - a Randomized Controlled Trial (COLDSNAP-2)


Sponsor

Technical University of Munich

Enrollment

850 participants

Start Date

Nov 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two ways to remove medium-sized colon polyps (10–15 mm) during a colonoscopy: using heat (hot snare) versus no heat (cold snare). The goal is to find out which method more completely removes the polyp while being safer and causing fewer complications. **You may be eligible if...** - You are scheduled for a colonoscopy - At least one polyp between 10 and 15 mm has been found in your colon or rectum - You have provided written consent to participate **You may NOT be eligible if...** - You are in very poor overall health (highest-risk surgery category) - You have severe, active inflammatory bowel disease (e.g., Crohn's or ulcerative colitis flare) - You are on blood thinners or dual antiplatelet medications (e.g., aspirin plus clopidogrel) - Your colonoscopy is being done as an emergency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREActive Comparator: Hot Snare Polypectomy

Hot Snare Polypectomy with the use of electrocautery for the resection of polyps.

PROCEDUREExperimental: Cold Snare Polypectomy

Cold Snare Polypectomy without the use of electrocautery for the resection of polyps.


Locations(1)

Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technische Universität München

München, Bavaria, Germany

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NCT04816292


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