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Improving Quality of Colonoscopy Using a 3D-imager

This study has been completed.
Sponsor:
Information provided by:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT00519129
First received: August 21, 2007
Last updated: August 17, 2011
Last verified: August 2011
History of Changes

August 21, 2007
August 17, 2011
August 2007
August 2010   (final data collection date for primary outcome measure)
  • pain during coloscopy [ Time Frame: instant ] [ Designated as safety issue: No ]
  • Time used to reach the coecum [ Time Frame: instant ] [ Designated as safety issue: No ]
  • pain during coloscopy [ Time Frame: instant ]
  • Time used to reach the coecum [ Time Frame: instant ]
Complete list of historical versions of study NCT00519129 on ClinicalTrials.gov Archive Site
  • coecum-intubation rate [ Time Frame: instant ] [ Designated as safety issue: No ]
  • level achieved when the coecum can not be reached [ Time Frame: instant ] [ Designated as safety issue: No ]
  • Need for assistance by a colleague [ Time Frame: instant ] [ Designated as safety issue: No ]
  • Need for analgetics [ Time Frame: instant ] [ Designated as safety issue: No ]
  • Pain during the first 24 hours after coloscopy [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Polyp detection rate [ Time Frame: instant ] [ Designated as safety issue: No ]
  • coecum-intubation rate [ Time Frame: instant ]
  • level achieved when the coecum can not be reached [ Time Frame: instant ]
  • Need for assistance by a colleague [ Time Frame: instant ]
  • Need for analgetics [ Time Frame: instant ]
  • Pain during the first 24 hours after coloscopy [ Time Frame: 24 hours ]
  • Polyp detection rate [ Time Frame: instant ]
Not Provided
Not Provided
 
Improving Quality of Colonoscopy Using a 3D-imager
Magnetic Endoscopic Imaging Versus Standard Colonoscopy in a Routine Colonoscopy Setting: A Randomised Controlled Trial

Coloscopy may be a painful procedure for the patient. This is due to a loop-formation of the coloscope. A 3D-real time imager produced by Olympus creates a real-time image of the scope while a traditional fluoroscopy device will only show instant pictures. We want to investigate whether the 3D-imager causes the patient less pain and is more time consuming than ordinary fluoroscopy

Results published in Holme et.al. Gastrointestinal Endoscopy 2011;73:1215-1222.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Pain During Colonoscopy
Device: 3D-imager
3D-imager vs fluoroscopy during coloscopy
Other Name: Skopguide
Not Provided
Holme Ö, Höie O, Matre J, Stallemo A, Garborg K, Hasund A, Wiig H, Hoff G, Bretthauer M. Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial. Gastrointest Endosc. 2011 Jun;73(6):1215-22. Epub 2011 Apr 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients referred for coloscopy on an out-patient basis

Exclusion Criteria:

  • Pregnancy
  • Pacemaker
  • Lack of ability to understand information given
  • Prior resection of the colon/rectum
  • Demanding analgetics prior to start of procedure
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00519129
SSHF-Colon-1
Yes
Sorlandet Hospital HF
Sorlandet Hospital HF
Not Provided
Study Director: Geir S Hoff, PhD
Sorlandet Hospital HF
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP