Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps

Study Overview
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Brief Summary
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Most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm. However, complete removal of diminutive polyps is required to prevent tumor recurrence and development of potential interval cancers. Currently, a variety of polypectomy techniques such as hot snare, cold snare, and cold forceps polypectomy are frequently used for the removal of diminutive colorectal polyps. In regard to the completeness of polypectomy, there are few data comparing cold snare polypectomy with cold forceps biopsy technique for removal of diminutive (1-5 mm) colorectal polyps. The aim of this study is to compare cold snare polypectomy with cold forceps polypectomy using double biopsy technique for removal of diminutive colorectal polyps.

Official Title
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Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps: a Prospective Randomized Trial

Conditions
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Polyp of Large Intestine

Intervention / Treatment
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* Procedure: removal of eligible polyps using cold snare polypectomy technique
* Procedure: removal of eligible polyps using double biopsy technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over the age of 20 Informed consent Exclusion Criteria: Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy Known existing bleeding tendency (thrombocytopenia or prolonged INR) Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis) ASA class III or more Pregnancy Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Ages Eligible for Study
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Minimum Age: 20 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold snare polypectomy<br> | Procedure: removal of eligible polyps using cold snare polypectomy technique<br>* Snare polypectomy using a mini (10 mm open diameter) size electrosurgical snare without application of electrocautery<br>|
| Experimental: Double biopsy polypectomy<br> | Procedure: removal of eligible polyps using double biopsy technique<br>* Cold forceps polypectomy using a standard- capacity forceps with double biopsy technique (two bites per one forceps pass)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete histologic polyp eradication rate |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken for polypectomy (complete visual eradication of each polyp) | time from polyp resection to tissue retrieval | 2 weeks | 
| Successful tissue retrieval rate of removed tissues |  | 2 weeks | 
| Rates of adverse events | Adverse events include postpolypectomy bleeding and others (polypectomy syndrome or perforation). | 4 weeks | 
| Complete visual polyp eradication rate |  | 2 weeks |