The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
570
Qualifying polyps randomized to Cold Snare Piecemeal Resection (CSPR) will be removed using cold snare techniques (no electrocautery, no submucosal injection.)
Qualifying polyps randomized to Cold Snare Endoscopic Mucosal Resection (Cold EMR) will be removed using cold snare techniques (no electrocautery, with submucosal injection.)
Indiana University
Indianapolis, Indiana, United States
Efficacy of Resection (Central Post-Resection Biopsies)
Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.
Time frame: 1 day
Efficacy of Resection (Peripheral Post-Resection Biopsies)
Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.
Time frame: 1 day
Polyp Resection Time
The time it takes to remove the polyp completely
Time frame: 1 day
Resection Preparation Time
The time it takes to prepare for polyp removal
Time frame: 1 day
Total Procedure Time
The total time it takes to complete the colonoscopy procedure
Time frame: 1 day
Adverse Events
The number of complications for each randomization arm during and after the procedure
Time frame: 30 Days
Rate of Recurrence at First Surveillance Colonoscopy for Polyps ≥ 20mm
The recurrence rate of serrated lesions ≥ 20mm measured at the first follow-up colonoscopy
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
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