Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: a Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the effects of complete versus no defect closure after endoscopic mucosal resection (EMR) for large (20mm or larger) flat colorectal polyps, also known as laterally spreading lesions (LSLs). The study aims to compare the rates of adverse events, such as delayed bleeding and perforation, and to assess lesion recurrence after EMR. This is an open-label, randomized controlled trial conducted across multiple centers, designed to determine if complete defect closure reduces complications compared to no closure. Participants undergoing EMR will be randomly assigned to one of two groups. In the experimental group, after EMR with thermal ablation, endoscopists will perform complete prophylactic defect closure using at least one new generation closure device. In the control group, EMR will be performed as usual without prophylactic defect closure unless there is a significant risk or presence of perforation. For both groups, tattoos will be placed around the largest lesion to mark the resection site. Follow-up colonoscopies will be scheduled at 6 and 18 months to monitor for lesion recurrence. During the study, patients will be contacted between 14 and 44 days after EMR to check for any adverse events, and their medical records will be reviewed for emergency visits related to these events. Follow-up colonoscopies will include visual examination of the resection scars and biopsies to detect recurrence. Endoscopists will use photographs to document lesions before and after treatment. The main outcomes measured are delayed bleeding and perforation within 14 days, as well as lesion recurrence at 6 months. The total duration of participation includes initial EMR, follow-up contacts, and colonoscopies up to 18 months after treatment.

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