Evaluation of the Use of Cap in Improving the Performance of Colonoscopy
NCT ID: NCT00930462
Last Updated: 2009-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
400 participants
INTERVENTIONAL
2008-03-31
2009-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Conventional colonoscopy
No cap fitted on the colonoscopes for this group.
No interventions assigned to this group
Cap-assisted colonoscopy
Cap (Olympus Medical Systems: D-201-15004, D-201-14304 and D-201-12704)
Plastic cap fitted on the colonoscope
Interventions
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Cap (Olympus Medical Systems: D-201-15004, D-201-14304 and D-201-12704)
Plastic cap fitted on the colonoscope
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy.
* Severe co-morbidities.
* Tertiary referral for endo-mucosal resection.
* Acute surgical conditions such as severe colitis, toxic megacolon, ischemic colitis, acute gastrointestinal bleeding.
18 Years
ALL
No
Sponsors
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Royal Prince Alfred Hospital, Sydney, Australia
OTHER
Responsible Party
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Royal Prince Alfred Hospital
Principal Investigators
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Arthur J Kaffes, FRACP
Role: PRINCIPAL_INVESTIGATOR
Royal Prince Alfred Hospital, Sydney
Locations
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Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Countries
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References
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Lee YT, Lai LH, Hui AJ, Wong VW, Ching JY, Wong GL, Wu JC, Chan HL, Leung WK, Lau JY, Sung JJ, Chan FK. Efficacy of cap-assisted colonoscopy in comparison with regular colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2009 Jan;104(1):41-6. doi: 10.1038/ajg.2008.56.
Kondo S, Yamaji Y, Watabe H, Yamada A, Sugimoto T, Ohta M, Ogura K, Okamoto M, Yoshida H, Kawabe T, Omata M. A randomized controlled trial evaluating the usefulness of a transparent hood attached to the tip of the colonoscope. Am J Gastroenterol. 2007 Jan;102(1):75-81. doi: 10.1111/j.1572-0241.2006.00897.x. Epub 2006 Nov 13.
Harada Y, Hirasawa D, Fujita N, Noda Y, Kobayashi G, Ishida K, Yonechi M, Ito K, Suzuki T, Sugawara T, Horaguchi J, Takasawa O, Obana T, Oohira T, Onochi K, Kanno Y, Kuroha M, Iwai W. Impact of a transparent hood on the performance of total colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):637-44. doi: 10.1016/j.gie.2008.08.029.
Shida T, Katsuura Y, Teramoto O, Kaiho M, Takano S, Yoshidome H, Miyazaki M. Transparent hood attached to the colonoscope: does it really work for all types of colonoscopes? Surg Endosc. 2008 Dec;22(12):2654-8. doi: 10.1007/s00464-008-9790-6. Epub 2008 Feb 23.
Tee HP, Corte C, Al-Ghamdi H, Prakoso E, Darke J, Chettiar R, Rahman W, Davison S, Griffin SP, Selby WS, Kaffes AJ. Prospective randomized controlled trial evaluating cap-assisted colonoscopy vs standard colonoscopy. World J Gastroenterol. 2010 Aug 21;16(31):3905-10. doi: 10.3748/wjg.v16.i31.3905.
Other Identifiers
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X07-0107
Identifier Type: -
Identifier Source: secondary_id
CAPCOLON
Identifier Type: -
Identifier Source: org_study_id