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

This study has been withdrawn prior to enrollment.
(Caps became unavailable by manufacturer)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01126632
First Posted: May 20, 2010
Last Update Posted: January 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nova Scotia Health Authority
  Purpose
Observing the effects of an Olympus cap on the visibility and in adenoma detection during colonoscopy.

Condition
Colonoscopy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Nova Scotia Health Authority:

Primary Outcome Measures:
  • cap-assisted colonoscopy compared visibility with standard colonoscopy [ Time Frame: 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:
  • Polyp detection rate [ Time Frame: 4 months ]
    Number of Polyps detected per procedure using the cap. To see if it is more visible.

  • Adenoma Detection [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 4 months ]
    Time to cecum

  • Total time for colonoscopy [ Time Frame: 4 months ]
  • Complication Rate [ Time Frame: 4 months ]
    Amount of complications during colonoscopies

  • Procedure indication [ Time Frame: 4 months ]

Enrollment: 0
Study Start Date: June 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cap Assisted Colonoscopy
Patients receiving colonoscopies where scope is fitted with cap
Standard Colonoscopy
Patients receiving standard colonoscopy without the cap on the scope

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Endoscopy Clinic- Patients already receiving colonoscopies
Criteria

Inclusion Criteria:

  • Patients already booked for a colonoscopy

Exclusion Criteria:

  • History of Colorectal Cancer
  • Severe colitis
  • Cancer
  • poor bowel prep
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126632


Locations
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
Principal Investigator: Donald G MacIntosh, MD Nova Scotia Health Authority
  More Information

Publications:
Responsible Party: Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01126632     History of Changes
Other Study ID Numbers: CAC Study
First Submitted: May 15, 2010
First Posted: May 20, 2010
Last Update Posted: January 28, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study was terminated

Keywords provided by Nova Scotia Health Authority:
Colonoscopy