NCT00930462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

Enrollment Period

11 months

First QC Date

June 26, 2009

Last Update Submit

June 29, 2009

Conditions

Colonoscopy

Keywords

colonoscopycaphoodcecal intubation timepolyp detection rateperformance

Outcome Measures

Primary Outcomes (1)

  • Time to cecum

    One month

Secondary Outcomes (1)

  • Polyp detection rate

    One month

Study Arms (2)

Conventional colonoscopy

NO INTERVENTION

No cap fitted on the colonoscopes for this group.

Cap-assisted colonoscopy

EXPERIMENTAL
Device: Cap (Olympus Medical Systems: D-201-15004, D-201-14304 and D-201-12704)

Interventions

Cap (Olympus Medical Systems: D-201-15004, D-201-14304 and D-201-12704)DEVICE

Plastic cap fitted on the colonoscope

Also known as: D-201-15004, D-201-14304 and D-201-12704, Olympus Medical Systems, Tokyo, Japan.
Cap-assisted colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All colonoscopy patients referred for colonoscopy at Royal Prince Alfred Hospital.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Location

Related Publications (5)

  • 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.

    PMID: 19098847RESULT

  • 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.

    PMID: 17100978RESULT

  • 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.

    PMID: 19251004RESULT

  • 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.

    PMID: 18297353RESULT

  • 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.

    PMID: 20712051DERIVED

MeSH Terms

Conditions

Anterior polar cataract 2

Study Officials

  • Arthur J Kaffes, FRACP

    Royal Prince Alfred Hospital, Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2009

First Posted

June 30, 2009

Study Start

March 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

June 30, 2009

Record last verified: 2009-06

Locations

AU(1)