Actively Recruiting
Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-02-11
686
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Patients undergoing EMR for a large (20mm or larger) colorectal laterally spreading lesion
- Patients able to provide written informed consent for participation
You will not qualify if you...
- History of inflammatory bowel disease
- Undergoing non-elective colonoscopy
- Poor general health classified as American Society of Anesthesiologists class greater than III
- Blood clotting disorders or low platelets (INR 1.5 or higher, platelets below 50 x 10^9/L)
- Presence of pedunculated polyps
- Signs of deep invasive cancer in the colon
- Invasion of appendiceal or terminal ileum areas
- Current pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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