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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: A Prospective Randomised Controlled Trial Comparing Cap-Assisted Colonoscopy Versus Standard Colonoscopy

Resource links provided by NLM:


Further study details as provided by Royal Prince Alfred Hospital, Sydney, Australia:

Primary Outcome Measures:
  • Time to cecum [ Time Frame: One month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Polyp detection rate [ Time Frame: One month ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: March 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: June 26, 2009
Last Updated: June 29, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Royal Prince Alfred Hospital, Sydney, Australia:
colonoscopy
cap
hood
cecal intubation time
polyp detection rate
performance

ClinicalTrials.gov processed this record on August 25, 2014