About this trial
This multicenter, prospective, randomized non inferiority trial, conducted at four Israeli hospitals, will evaluate whether a relaxed surveillance strategy after piecemeal endoscopic mucosal resection (pEMR) of large non pedunculated colorectal polyps (LNPCPs, ≥20 mm) is as safe and effective as the current standard intensive surveillance. Approximately 760 adults undergoing complete pEMR with margin ablation will be randomized 1:1 into:
Standard Surveillance: Colonoscopy at 6, 18, and 48 months
Relaxed Surveillance: Colonoscopy at 12 and 48 months
All colonoscopies will be performed using high definition white light and narrow band imaging, with biopsies obtained only if recurrence is suspected. The investigators hypothesize that a relaxed surveillance strategy will be non inferior to the current standard intensive surveillance. If non inferiority is demonstrated, the study may support guideline changes toward reduced surveillance frequency after pEMR with margin ablation, potentially decreasing patient burden and healthcare costs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and older
Undergoing pEMR of LNPCPs
Able to provide informed consent and comply with follow-up requirements
Disqualifiers
Patients with invasive cancer identified during the index procedure
en bloc resection
Patients unable to attend follow-up colonoscopies due to comorbid conditions
Patients who require additional surgery for polyp removal or other complications
Trial design
Parallel
Treatments tested in this trial
Colonoscopy after bowel cleansing
Procedure/SurgeryThe procedure is performed by experienced endoscopists using high-definition white light and narrow-band imaging to carefully inspect the colon and assess the resection site. Biopsies are taken only if abnormal tissue or recurrence is suspected.
Treatment groups
Trial outcomes
Primary outcomes
Rate of residual/recurrent adenoma (RRA) at first and second surveillance colonoscopy.
Sponsors and contacts
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