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Evaluation of the Use of Cap in Improving the Performance of Colonoscopy

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ClinicalTrials.gov Identifier: NCT00930462
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : June 30, 2009
Sponsor:
Information provided by:
Royal Prince Alfred Hospital, Sydney, Australia

Tracking Information
First Submitted Date  ICMJE June 26, 2009
First Posted Date  ICMJE June 30, 2009
Last Update Posted Date June 30, 2009
Study Start Date  ICMJE March 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
Time to cecum [ Time Frame: One month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
Polyp detection rate [ Time Frame: One month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Use of Cap in Improving the Performance of Colonoscopy
Official Title  ICMJE A Prospective Randomised Controlled Trial Comparing Cap-Assisted Colonoscopy Versus Standard Colonoscopy
Brief Summary The aim of this study is to compare the colonoscopy success rate, cecal time and polyp detection rate between cap-fitted colonoscopy and conventional colonoscopy.
Detailed Description

Colonoscopic examination has been used in clinical practice for approximately 40 years. Despite the fact that colonoscopy is widely available and is performed by many experienced colonoscopists there are concerns about the quality of colonoscopy as measured by several technical endpoints such as rate of failed caecal intubation and polyp miss rate. A large population-based study revealed 13.1% of colonoscopies failed to reach the cecum. In addition, one large review of back-to-back colonoscopies showed polyp miss rates of 24% for adenoma.

One potentially promising technique is cap-assisted colonoscopy. A transparent cap (or "hood") is a simple plastic device that can be attached to the tip of a colonoscope before performing the colonoscopy. Several randomized trials from Japan have mixed results regarding improved cecal intubation times and polyp detection rates. A recent large study from Hong Kong showed improved time to cecum but a reduced polyp detection rate. To date there is no large randomized study using the cap in a western population, in whom the colorectal cancer (CRC) incidence is known to be higher. We plan to conduct a randomized controlled trial to investigate the usefulness of cap-assisted colonoscopy in a Western population.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Colonoscopy
Intervention  ICMJE Device: Cap (Olympus Medical Systems: D-201-15004, D-201-14304 and D-201-12704)
Plastic cap fitted on the colonoscope
Other Names:
  • D-201-15004, D-201-14304 and D-201-12704
  • Olympus Medical Systems, Tokyo, Japan.
Study Arms  ICMJE
  • No Intervention: Conventional colonoscopy
    No cap fitted on the colonoscopes for this group.
  • Experimental: Cap-assisted colonoscopy
    Intervention: Device: Cap (Olympus Medical Systems: D-201-15004, D-201-14304 and D-201-12704)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2009)
400
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All colonoscopy patients referred for colonoscopy at Royal Prince Alfred Hospital.

Exclusion Criteria:

  • Prior colonic resection
  • Pregnancy.
  • Severe co-morbidities.
  • Tertiary referral for endo-mucosal resection.
  • Acute surgical conditions such as severe colitis, toxic megacolon, ischemic colitis, acute gastrointestinal bleeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00930462
Other Study ID Numbers  ICMJE CAPCOLON
X07-0107
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoi-Poh Tee, Royal Prince Alfred Hospital
Study Sponsor  ICMJE Royal Prince Alfred Hospital, Sydney, Australia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arthur J Kaffes, FRACP Royal Prince Alfred Hospital, Sydney
PRS Account Royal Prince Alfred Hospital, Sydney, Australia
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP