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Improving Quality of Colonoscopy Using a 3D-imager

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519129
First Posted: August 22, 2007
Last Update Posted: August 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sorlandet Hospital HF
August 21, 2007
August 22, 2007
August 18, 2011
August 2007
August 2010   (Final data collection date for primary outcome measure)
  • pain during coloscopy [ Time Frame: instant ]
  • Time used to reach the coecum [ Time Frame: instant ]
Same as current
Complete list of historical versions of study NCT00519129 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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
Intervention Model: Parallel Assignment
Masking: None (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. doi: 10.1016/j.gie.2011.01.054. 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00519129
SSHF-Colon-1
Yes
Not Provided
Not Provided
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