Randomized Trial of Complete Defect Closure Versus No Closure After Endoscopic Removal of Large Flat Colorectal Polyps

What this Trial Is About

Researchers are evaluating the effects of complete versus no defect closure after endoscopic mucosal resection EMR for large flat colorectal polyps, also called laterally spreading lesions LSLs measuring 20 mm or more. The study aims to compare the rates of adverse events, such as delayed bleeding and perforation, and assess lesion recurrence after EMR. This is a randomized controlled trial with two parallel groups to test if complete defect closure reduces complications compared to no closure. Participants undergoing planned EMR will be randomly assigned to either a control group where no prophylactic defect closure is performed following EMR or an experimental group receiving complete defect closure using new generation closure devices. EMR will be performed as standard care with submucosal injection and electrocautery snare resection. Multiple large polyps will be marked with tattoos to identify the study lesion. Follow-up colonoscopies will be done at 6 and 18 months to check for recurrence. During the study, patients will be contacted 14 to 44 days after EMR to monitor for adverse events and their medical records will be reviewed for emergency visits related to complications. Follow-up colonoscopies will assess the resection site visually and with biopsies to detect lesion recurrence. Photos will document the lesion and resection site. Researchers will measure delayed bleeding and perforation within 14 days and lesion recurrence at 6 months. The study emphasizes careful follow-up and multiple contact methods to reduce loss to follow-up, with participation lasting up to about 18 months.

Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps