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NOT YET RECRUITING
NCT07328308
NA

Delayed Surveillance Colonoscopy Following Piecemeal EMR

Sponsor: Rambam Health Care Campus

View on ClinicalTrials.gov

Summary

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.

Official title: Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

760

Start Date

2026-01

Completion Date

2031-01

Last Updated

2026-01-09

Healthy Volunteers

No

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.

Locations (1)

Rambam Medical Center

Haifa, Israel