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Colonoscopy Endoguide in Specialist Practice

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01055782
First Posted: January 26, 2010
Last Update Posted: June 11, 2012
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.
Collaborators:
Danish Medical Association
Surgical Clinic, Allerød, Denmark
Information provided by (Responsible Party):
Lene Hendel, The Specialist Doctors at Rolighedsvej
January 24, 2010
January 26, 2010
March 23, 2012
May 28, 2012
June 11, 2012
November 2009
April 2011   (Final data collection date for primary outcome measure)
Completed Colonoscopy [ Time Frame: immediately after colonoscopy ]
Same as current
Complete list of historical versions of study NCT01055782 on ClinicalTrials.gov Archive Site
Perception of Pain [ Time Frame: After endoscopy (within 10mins) and 1 day after endoscopy ]
VAS (Visual Analogue Scale), 0 - 10. VAS 0 is no pain, VAS 10 is max pain. Scores on a scale
Perception of Pain [ Time Frame: same day and day after colonoscopy ]
Not Provided
Not Provided
 
Colonoscopy Endoguide in Specialist Practice
Kan Anvendelse af Endoskopisk Positioneringsudstyr Ved coloskopiundersøgelsen (kikkertundersøgelse af Tarmen) i en højt Specialiseret Praksis Forbedre Patientens Subjektive Kvalitetsoplevelse (Smerteperception)?

The study includes 700 patients referred for colonoscopy are randomized to colonoscopy with or without endoguide.

The study will investigate whether the endoguide improves success rate and the patient's perception of pain.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Colonoscopy
  • Pain
Device: Endoguide
Use of endoguide to facilitate completion of endoscopy
  • Experimental: With endoguide
    Colonoscopy completed with endoguide
    Intervention: Device: Endoguide
  • No Intervention: Without endoguide
    Colonoscopy completed without endoguide
Bak-Christensen A, Knudsen E, Hendel J, Ifaoui IB, Lehrskov-Schmidt L, Hendel L. Colonoscopy results are not enhanced by use of magnet endoguide in specialist practice. Dan Med J. 2013 Jun;60(6):A4611.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1004
June 2012
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Informed consent provided

Exclusion Criteria:

  • Informed consent not provided or not possible to obtain
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01055782
H-1-2009-80
No
Not Provided
Not Provided
Lene Hendel, The Specialist Doctors at Rolighedsvej
The Specialist Doctors at Rolighedsvej
  • Danish Medical Association
  • Surgical Clinic, Allerød, Denmark
Not Provided
The Specialist Doctors at Rolighedsvej
June 2012

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