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

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

Study Overview

• Status: Withdrawn
• Conditions: 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 Type: Observational

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Capital District Health Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Endoscopy Clinic- Patients already receiving colonoscopies

Description

Inclusion Criteria:

• Patients already booked for a colonoscopy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cap Assisted Colonoscopy; Patients receiving colonoscopies where scope is fitted with cap
Standard Colonoscopy; Patients receiving standard colonoscopy without the cap on the scope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cap-assisted colonoscopy compared visibility with standard colonoscopy	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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyp detection rate	Number of Polyps detected per procedure using the cap. To see if it is more visible.	4 months
Adenoma Detection	number of adenomatous polyps detected per procedure. To see if it is more visible using the cap as to not using the cap.	4 months
Advanced lesion detection rate	(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.	4 months
Cecal Intubation Rate	Time to cecum	4 months
Total time for colonoscopy		4 months
Complication Rate	Amount of complications during colonoscopies	4 months
Procedure indication		4 months

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Donald G MacIntosh, MD, Nova Scotia Health Authority

Publications and helpful links

General Publications

• Lee YT, Lai LH, Hui AJ, Wong VW, Ching JY, Wong GL, Wu JC, Chan HL, Leung WK, Lau JY, Sung JJ, Chan FK. Efficacy of cap-assisted colonoscopy in comparison with regular colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2009 Jan;104(1):41-6. doi: 10.1038/ajg.2008.56.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: May 15, 2010
• First Submitted That Met QC Criteria: May 18, 2010
• First Posted (Estimate): May 20, 2010

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Colonoscopy
• Other Study ID Numbers: CAC Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study was terminated