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Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Summary
The goal of this clinical trial is to compare adverse even rates after EMR for large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions, LSLs) when performing complete or no defect closure. It will also evaluate lesion recurrence after EMR for large colorectal LSLs. The hypothesis is that performing complete defect closure following EMR of large colorectal LSLs will result in lower rates of adverse events compared to cases where no defect closure is performed. For participants with planned EMR, endoscopists will perform EMRs as per standard of care and: * prophylactic defect closure will either not be performed (control group), or will be performed (experimental group); * then, patients will be called between 14 and 44 days after EMR to assess for possible adverse events, and electronic medical files will be verified for emergency room visits and healthcare received for an adverse event; * finally, patients will undergo follow-up colonoscopy 6 months and 18 months after randomization.
Official title: Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
686
Start Date
2025-02
Completion Date
2027-07
Last Updated
2025-02-11
Healthy Volunteers
No
Conditions
Interventions
Prophylactic defect closure
Endoscopists will use at least one new generation closure device to approximate the healthy mucosal surrounding the submucosal defect to ensure complete defect closure. Adequate apposition of the mucosal defect margins will be achieved when no visible submucosal areas \>3 mm along the closure line are present.
No prophylactic defect closure
After performing EMR with thermal ablation, prophylactic defect closure will not be performed.
Locations (1)
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada