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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:

Study Description
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.


Study Design

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
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

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.
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): NCT00930462


Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Sponsors and Collaborators
Royal Prince Alfred Hospital, Sydney, Australia
Investigators
Principal Investigator: Arthur J Kaffes, FRACP Royal Prince Alfred Hospital, Sydney
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoi-Poh Tee, Royal Prince Alfred Hospital
ClinicalTrials.gov Identifier: NCT00930462     History of Changes
Other Study ID Numbers: CAPCOLON
X07-0107
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:
colonoscopy
cap
hood
cecal intubation time
polyp detection rate
performance