Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy

Study Overview
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Brief Summary
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The focus of the study is to evaluate impact of cold forcep and cold snare in achieving complete resection during polypectomy of polyps <=3mm during colonoscopy.

Detailed Description
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The details of the proposed study are as follows: Experimental group: using cold forceps for polyps <=3mm of the colon Control group: using cold snare for polyps <=3mm of the colon Methods: Colonoscopy will be performed in the same standard of care manner as if no study was taking place. If polyps <=3mm are identified, the endoscopist is randomized to performing polypectomy with cold forcep or cold snare. After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion. The polyp as well as well as the two biopsies are reviewed by a pathologist.

Official Title
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Randomized Controlled Trial Investigating Cold Snare aNd Forcep polypectomY Among Small POLYPs in Rates of Complete Resection: the TINYPOLYP Trial.

Conditions
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Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyp of Colon

Intervention / Treatment
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* Procedure: Cold forcep polypectomy
* Procedure: Cold snare polypectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years or older Polyps <=3mm Exclusion Criteria: Pregnant Inflammatory bowel disease Polyposis syndromes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold forcep<br>Cold forcep polypectomy performed for polyps <=3mm. | Procedure: Cold forcep polypectomy<br>* Removal of appropriate polyps using cold forceps until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.<br>|
| Experimental: Cold snare<br>Cold forcep polypectomy performed for polyps <=3mm. | Procedure: Cold snare polypectomy<br>* Removal of appropriate polyps using cold snare until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completeness of resection | The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resection | The time between the forceps or snare is introduced till the polyp is removed and retrieved will be compared. | During the procedure | 
| Number of forcep bites or snare attempts | We will compare the number of bites or snare attempts needed to remove the tissue adequately to the endoscopist's judgment. | During the procedure | 
| Complications | We will compare rates of complications including perforation and immediate post-polypectomy bleeding, early post-polypectomy bleed (within 24 hours) and delayed post polypectomy bleed (between 24 hours and 30 days). Early post-polypectomy bleed and delayed post-polypectomy bleed is evaluated based on emergency room (ER) visit, inpatient stay, transfusion needed, repeat colonoscopy required, surgical intervention required, and mortality. | 4 weeks |