Colonoscopy with EndoCuff vs conventional colonoscopy A randomized controlled trial

Completed

• Conditions: 10017987; colonic polyp; colorectal adenoma; precursor coloncancer; 10017990

• Registration Number: NL-OMON39964
• Lead Sponsor: Stichting Procolo, centrum voor dikkedarmonderzoek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1058

Inclusion Criteria

*Aged 45 years and older
*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
*Signed written informed consent
*ASA class I, II or III

Exclusion Criteria

*Polyposis syndromes
*Inflammatory bowel disease (active disease or surveillance)
*Previous partial colonic resection
*Known conditions that require the use of a paediatric colonoscope (severe diverticulosis or abdominal surgery in the medical history)
*Colonoscopy after polyp detection with CT-colonography
*Known colonic stricture
*Any acute indication for colonoscopy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mean number of adenomas per patient<br /><br>Adenoma detection rate (percentage of colonoscopies where at least one adenoma<br /><br>is found)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Polyp detection rate & number of polyps per patient<br /><br>* Flat adenoma detection rate<br /><br>* Polyp retrieval rate<br /><br>* Cecal intubation rate and cecal intubation time<br /><br>* Discomfort during the procedure using the Gloucester Comfort scale<br /><br>* Subjective difficulty of the procedure as assessed by the endoscopist<br /><br>* Complication rate </p><br>