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
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy||Device: Cap (Olympus Medical Systems: D-201-15004, D-201-14304 and D-201-12704)||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- Time to cecum [ Time Frame: One month ]
- Polyp detection rate [ Time Frame: One month ]
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
|Australia, New South Wales|
|Royal Prince Alfred Hospital|
|Sydney, New South Wales, Australia|
|Principal Investigator:||Arthur J Kaffes, FRACP||Royal Prince Alfred Hospital, Sydney|