The European Polyp Surveillance study

Recruiting

• Conditions: 'adenoma'; 'polyp'; 10017934; 10017987

• Registration Number: NL-OMON55632
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 4707

Inclusion Criteria

- men and women age 40-74 years;
- cecal intubation during baseline colonoscopy
- adequate colonic cleansing, with Boston Bowel Cleansing Score >=2 points in
all colonic segments
- complete excision of all polyps at baseline colonoscopy findings
- randomization must be performed no longer than 26 weeks (182 days) from
completion date of baseline colonoscopy.

Exclusion Criteria

- lack of informed consent
- history of colorectal cancer or adenomas (prior to baseline colonoscopy)
- history of serrated polyps >= 10 mm in diameter at any colorectal location or
>= 5 mm if located proximal to the splenic flexure
- more than 10 adenomas
- incomplete colonoscopy
- incomplete endoscopic excision of polyps
- genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or
Lynch-like syndrome)
- inflammatory bowel disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint for all three studies is the incidence of CRC and advanced<br /><br>adenomas (advanced neoplasia) at years 3, 5 and 10, where applicable. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following endpoints will also be compared in the different arms in EPoS I<br /><br>and II, and presented in EPoS III:<br /><br>• Colorectal cancer mortality<br /><br>• Cost-effectiveness<br /><br>• Yield of advanced adenomas, (non-advanced) adenomas and serrated polyps<br /><br>• Adverse events</p><br>