Multicenter, randomised controlled trial comparing endoscopic Mucosal resection (EMR) And endoscopic submucosal dissecTIon (ESD) for resection of Large Distal non-pedunculated colorectal Adenomas
Recruiting
- Conditions
- 10017934adenoma polyp
- Registration Number
- NL-OMON47389
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 254
Inclusion Criteria
- non-pedunculated polyp larger than 20 mm in the rectum, sigmoid or descending colon found during colonoscopy
- indication for endoscopic treatment
- >=18 years old
- written informed consent
Exclusion Criteria
suspicion of malignancy, as determined by endoscopic findings (invasive Kudo pit pattern, Hiroshima type C) or proven malignancy at histology
- prior endoscopic resection attempt
- presence of synchronous distal advanced carcinoma that requires surgical resection
- the risk exceeds the benefit of endoscopic treatment, such as patient*s with an extremely poor general condition or a very short life expectancy
- the inability to provide informed consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- to compare the recurrence rate at follow-up colonoscopy after 6 months,<br /><br>observed from resected residual disease or, if not present, from biopsies of<br /><br>the scar</p><br>
- Secondary Outcome Measures
Name Time Method <p>- to compare the radical (R0-)resection rate, defined as dysplasia free<br /><br>vertical and lateral resection margins at histology<br /><br>- To compare the cost effectiveness at 36 months<br /><br>- To compare the perceived burden and quality of life among patients<br /><br>- To compare the surgical referral rate defined as the number of patients that<br /><br>are referred for surgical management at 36 months<br /><br>- To compare the complication rate<br /><br>- To compare the long-term recurrence rate at follow-up colonoscopy after 36<br /><br>months, observed from resected residual disease or, if not present, from<br /><br>biopsies of the scar</p><br>