Dutch National Prospective EMR Cohort

Recruiting

• Conditions: Large Bowel Polyp

• Registration Number: NCT03545061
• Lead Sponsor: Radboud University Medical Center

Brief Summary

A Prospective Study: Longterm Follow Up until S2 (2nd surveillance) at 18 months after EMR for Large Flat/Sessile Colonic Polyps.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-06-04
• Study Start: 2018-08-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-08
• Last Update Posted: 2020-10-09
• Primary Completion: 2022-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Flat or sessile polyp morphology (Paris classification 0-IIa/b/c, Is)
• Polyp size >20 mm
• Therapy: EMR
• Age > 18 years old
• Written informed consent

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Exclusion Criteria

• Participation in a competing study, such as the "CLIPPER trial" (registration number: NL62949.091.17).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence	6 months (S1) and 18 months (S2) after EMR	Pathological and endoscopical re-appearance of adenoma
Complications	30 days post EMR	Delayed bleeding, perforation and postpolypectomy syndrome

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands