Colonoscopy with EndoCuff vs conventional colonoscopy: A randomized controlled trial.
- Conditions
- -colonoscopy -colorectal cancer (CRC) -adenomas, adenoma miss rate -disposable device, the EndoCuff-adenoma detection rate (ADR)-mean number of adenomas per patient (MAP)In Dutch:-colonoscopiecolorectaal carcinoom-adenomen-hulpmiddel: Endocuff-adenoom detectie rate (ADR)
- Registration Number
- NL-OMON20756
- Lead Sponsor
- Academic Medical Centre
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 972
Inclusion Criteria
1. Aged 45 years and older;
2. Scheduled for colonoscopy for on of the following indications: polyp surveillance, changed bowel habits and/or
bloody stools or bowel complaints, FOBT+ screening, positive family history for CRC, abdominal pain;
Exclusion Criteria
1. Polyposis syndromes;
2. Inflammatory bowel disease (active disease or surveillance);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Mean number of adenomas per patient;<br /><br>2. Adenoma detection rate (percentage of colonoscopies where at least one adenoma is found).
- Secondary Outcome Measures
Name Time Method 1. Polyp detection rate & number of polyps per patient;<br /><br>2. Flat adenoma detection rate;<br /><br>3. Polyp retrieval rate;<br /><br>4. Cecal intubation rate and cecal intubation time;<br /><br>5. Discomfort during the procedure using the Gloucester Comfort scale;<br /><br>6. Subjective difficulty of the procedure as assessed by the endoscopist;<br /><br>7. Complication rate.