RecruitingNot ApplicableNCT06807073

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

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


Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

686 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether fully closing the wound site after endoscopic mucosal resection (EMR) — a procedure to remove large polyps from the colon without surgery — reduces the risk of complications like bleeding compared to partial or no closure. **You may be eligible if...** - You are 18 or older - You are scheduled for EMR to remove a large flat polyp or lesion (at least 20 mm) from the colon or rectum - You have provided written informed consent **You may NOT be eligible if...** - You have inflammatory bowel disease (Crohn's or ulcerative colitis) - Your colonoscopy is being done urgently (non-elective) - You are in poor general health (ASA classification above 3) - You have a blood clotting problem or low platelets that cannot be corrected - Your polyp is pedunculated (on a stalk) rather than flat - Your polyp shows signs of deep invasion into the bowel wall - Your polyp involves the appendix opening or extends into the small intestine - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREProphylactic 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.

PROCEDURENo 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06807073


Related Trials