Trials / Not Yet Recruiting
Not Yet RecruitingNCT07328308
Delayed Surveillance Colonoscopy Following Piecemeal EMR
Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 760 (estimated)
- Sponsor
- Rambam Health Care Campus · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-01-01
- Primary completion
- 2027-01-01
- Completion
- 2031-01-01
- First posted
- 2026-01-09
- Last updated
- 2026-01-09
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT07328308. Inclusion in this directory is not an endorsement.