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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• adult ≥18 years old

• patients undergoing EMR for a large (≥20mm) colorectal LSL

• patients providing written and informed consent for study participation.

Locations
Other Locations
Canada
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Time Frame
Start Date: 2025-02
Estimated Completion Date: 2027-07
Participants
Target number of participants: 686
Treatments
Experimental: Endoscopic Mucosal Resection (EMR) + prophylactic defect closure (defect closure)
Prophylactic defect closure will be performed using at least one new generation closure device.
Active_comparator: Endoscopic Mucosal Resection (EMR)
After performing EMR with thermal ablation, prophylactic defect closure will not be performed.
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov