Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial

Withdrawn

• Conditions: Colonoscopy

• Registration Number: NCT01126632
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

Observing the effects of an Olympus cap on the visibility and in adenoma detection during colonoscopy.

Detailed Description

To see if Colonoscopy with the CAP is able to give more visibility and to see if detection rate for adenomas, polyps are easier to detect.

Study Timeline

• Study First Submitted: 2010-05-15
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-20
• Study Start: 2010-06
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients already booked for a colonoscopy

Exclusion Criteria

• History of Colorectal Cancer
• Severe colitis
• Cancer
• poor bowel prep

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cap-assisted colonoscopy compared visibility with standard colonoscopy	4 months	Propose to perform a randomized controlled trial comparing cap-assisted colonoscopy with the standard colonoscopy to assess visibility. To see if it is easier to detect polyps, adenomas with the cap than without. This is standard procedure. Just comparing if it is better to use the cap during colonoscopy.

Secondary Outcome Measures

Name	Time	Method
Polyp detection rate	4 months	Number of Polyps detected per procedure using the cap. To see if it is more visible.
Adenoma Detection	4 months	number of adenomatous polyps detected per procedure. To see if it is more visible using the cap as to not using the cap.
Advanced lesion detection rate	4 months	(number of advanced lesions per procedure) defined as lesions with high-grade dysplasia, greater than 1 cm. size. To see if it is more visible using the cap as to not using the cap.
Cecal Intubation Rate	4 months	Time to cecum
Total time for colonoscopy	4 months
Complication Rate	4 months	Amount of complications during colonoscopies
Procedure indication	4 months

Trial Locations

Locations (1)

Capital District Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada