Delayed Surveillance Colonoscopy Following Piecemeal EMR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colonoscopy after bowel cleansing.
- Who it may be relevant to
- Registry conditions: Colon Cancer Prevention, Polyp Colorectal. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study
Overview
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.
Interventions
- Procedure Colonoscopy after bowel cleansing
The 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.
Primary outcome measures
- Rate of residual/recurrent adenoma (RRA) at first and second surveillance colonoscopy. [Time frame: From patient enrollment until the end of the 48 month follow up period]
Eligibility criteria
Inclusion criteria
- Adults aged 18 years and older
- Undergoing pEMR of LNPCPs
- Able to provide informed consent and comply with follow-up requirements
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Israel · 1 center
- Rambam Medical Center — Haifa
Identifiers
NCT: NCT07328308 · RMB-0069-25