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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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 criteria

Qualifiers

adult ≥18 years old

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

patients providing written and informed consent for study participation.

Disqualifiers

inflammatory bowel disease;

non-elective colonoscopy;

poor general health (American Society of Anesthesiologists classification >III);

coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets <50 x 109/L);

Trial design

Treatments tested in this trial

  • Prophylactic defect closure
  • No prophylactic defect closure

Treatment groups

686 Participants
are divided into 2 treatment groups