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

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

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.

Condition or disease Intervention/treatment Phase
Colonoscopy Device: Cap (Olympus Medical Systems: D-201-15004, D-201-14304 and D-201-12704) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: A Prospective Randomised Controlled Trial Comparing Cap-Assisted Colonoscopy Versus Standard Colonoscopy
Study Start Date : March 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
No Intervention: Conventional colonoscopy
No cap fitted on the colonoscopes for this group.
Experimental: Cap-assisted 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.

Primary Outcome Measures :
  1. Time to cecum [ Time Frame: One month ]

Secondary Outcome Measures :
  1. Polyp detection rate [ Time Frame: One month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00930462

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Australia, New South Wales
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Sponsors and Collaborators
Royal Prince Alfred Hospital, Sydney, Australia
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Principal Investigator: Arthur J Kaffes, FRACP Royal Prince Alfred Hospital, Sydney
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hoi-Poh Tee, Royal Prince Alfred Hospital Identifier: NCT00930462    
Other Study ID Numbers: CAPCOLON
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009
Keywords provided by Royal Prince Alfred Hospital, Sydney, Australia:
cecal intubation time
polyp detection rate