About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Indication for colonoscopy
at least 1 adenomatous polyp 10-15 mm
provided written informed consent
Disqualifiers
American Society of Anaesthesiologists class IV or higher
florid inflammatory bowel disease
emergency indication for colonoscopy
haemorrhagic diathesis
Trial design
Parallel
Treatments tested in this trial
Active Comparator: Hot Snare Polypectomy
Procedure/SurgeryHot Snare Polypectomy with the use of electrocautery for the resection of polyps.
Experimental: Cold Snare Polypectomy
Procedure/SurgeryCold Snare Polypectomy without the use of electrocautery for the resection of polyps.
Treatment groups
Trial outcomes
Primary outcomes
Complete resection rate
The histological complete resection rate, determined by pathologically negative margins of the specimen and no residual adenomatous material obtained from two/four biopsies of the resection site.
Secondary outcomes
En-bloc resection rate
Number of additional resections (snare/forceps) needed.
Rate of immediate bleeding with necessity of haemostasis
Immediate bleeding: Bleeding \>30 seconds after snaring.
Rate of impossible resection by CSP
An impossible resection by CSP needs electrocautery for successful resection.
Time required for resection
Time required for resection is the time between the insertion of the snare into working channel to the end of polyp resection. In the HSP group, it is defined as the start of submucosal injection until the end of polyp resection.
Sponsors and contacts
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