Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Royal Prince Alfred Hospital, Sydney, Australia
ClinicalTrials.gov Identifier:
NCT00930462
First received: June 26, 2009
Last updated: June 29, 2009
Last verified: June 2009

June 26, 2009
June 29, 2009
March 2008
February 2009   (final data collection date for primary outcome measure)
Time to cecum [ Time Frame: One month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00930462 on ClinicalTrials.gov Archive Site
Polyp detection rate [ Time Frame: One month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Use of Cap in Improving the Performance of Colonoscopy
A Prospective Randomised Controlled Trial Comparing Cap-Assisted Colonoscopy Versus Standard Colonoscopy

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Colonoscopy
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.
  • 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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
February 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00930462
CAPCOLON, X07-0107
No
Hoi-Poh Tee, Royal Prince Alfred Hospital
Royal Prince Alfred Hospital, Sydney, Australia
Not Provided
Principal Investigator: Arthur J Kaffes, FRACP Royal Prince Alfred Hospital, Sydney
Royal Prince Alfred Hospital, Sydney, Australia
June 2009

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