Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps

Study Overview
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Brief Summary
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This study aims to investigate the comparative effectiveness between polyp removal with or without electrical current. The investigators want to include 600 polyps in the trial. It is known that polyps have the potential to develop to cancer if left in situ, but the investigators do not know the best way to remove them completely.

Detailed Description
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In this study the investigators want to compare to widely used methods for polyp removal; hot and cold snare polypectomy. There has not been performed any big studies on this subject earlier, but current knowledge indicates that hot polypectomy (i.e. with use of electrical current) is somewhat better with regard to complete resection of polyps compared to cold polypectomy (without electrical current). In this project the patients will be randomized to either hot or cold polypectomy. The investigators will distribute videos of how the polypectomies should be performed, and a gastroenterologist in the project group will instruct the doctors examining the patients to make sure that everyone performs polypectomy according to current guidelines. The study is designed as a non-inferiority trial.

Official Title
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Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps. A Randomized Controlled Trial

Conditions
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Colonic Polyps, Colorectal Neoplasms, Adenoma

Intervention / Treatment
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* Procedure: Polypectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient colonoscopy Signed, written informed consent At least one flat/sessile polyp sized 4-9 mm identified during colonoscopy Exclusion Criteria: Implanted cardiac electro converter Severe comorbidity (NYHA 3-4) Known coagulopathy (INR > 1,8) or resent use of any of the new oral anti-coagulant medications Platelet count < 100 Resent use of clopidogrel or other non-acetylsalicylic acid platelet inhibitor (Last dose < 5 days before the procedure) Previous biopsy or attempt of polypectomy of the polyp considered for inclusion in the trial

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cold polypectomy<br>Patients in this arm will have their polyps removed by cold polypectomy, i.e. a metal sling that is closed around the basis of the polyp, and the polyp is cut off. After removal there will be taken biopsies from the resection margins, and both the polyp and the biopsies will be examined by a histopathologist to see if the polyp is removed completely. | Procedure: Polypectomy<br> <br> |
| Active Comparator: Hot polypectomy<br>Patients in this arm will have their polyps removed by hot polypectomy, i.e. a metal sling taht is closed around the basis of the polyp, electrical currents is applied, and the polyp is cut off. After removal there will be taken biopsies from the resection margins, and both the polyp and the biopsies will be examined by a histopathologist to see if the polyp is removed completely. | Procedure: Polypectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete resection rate | We want to measure the rate of polyps that are resected completely, both with biopsies from the margin and the histopathologists evaluation of the resection margins of the polyp itself. | Hopefully within 4 weeks, when the histopathologist has examined the biopsies | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | We want to register early (during the procedure) and late (within 4 weeks after the procedure) complications. Complications we will record is bleeding/blood in the stool, perforation and patient contact with health care provider | 4 weeks | 
| Factors explaining the primary outcome | Patient characteristics | During the hospital stay and up to 4 weeks. | 
| Factors explaining the primary outcome | Doctor characteristics | During the hospital stay and up to 4 weeks | 
| Factors explaining the primary outcome | Procedure characteristics | During the hospital stay and up to 4 weeks | 
| Factors explaining the primary outcome | Histology of polyps, correlation between resection margins and biopsies, correlation between optical and histopathological diagnosis | During the hospital stay and up to 4 weeks |