Evaluation of the Use of Cap in Improving the Performance of Colonoscopy - Full Text View

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:

MedlinePlus related topics: Colonoscopy

U.S. FDA Resources

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

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:

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.

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. 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 Suppl):637-44.

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. Epub 2008 Feb 23.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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 May 19, 2013