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Colonoscopy Endoguide in Specialist Practice

This study has been completed.
Danish Medical Association
Surgical Clinic, Allerød, Denmark
Information provided by (Responsible Party):
Lene Hendel, The Specialist Doctors at Rolighedsvej Identifier:
First received: January 24, 2010
Last updated: June 6, 2012
Last verified: June 2012

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.

Condition Intervention
Device: Endoguide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Kan Anvendelse af Endoskopisk Positioneringsudstyr Ved coloskopiundersøgelsen (kikkertundersøgelse af Tarmen) i en højt Specialiseret Praksis Forbedre Patientens Subjektive Kvalitetsoplevelse (Smerteperception)?

Resource links provided by NLM:

Further study details as provided by The Specialist Doctors at Rolighedsvej:

Primary Outcome Measures:
  • Completed Colonoscopy [ Time Frame: immediately after colonoscopy ]

Secondary Outcome Measures:
  • 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

Enrollment: 1004
Study Start Date: November 2009
Study Completion Date: June 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: With endoguide
Colonoscopy completed with endoguide
Device: Endoguide
Use of endoguide to facilitate completion of endoscopy
No Intervention: Without endoguide
Colonoscopy completed without endoguide


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed consent provided

Exclusion Criteria:

  • Informed consent not provided or not possible to obtain
  Contacts and Locations
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Please refer to this study by its identifier: NCT01055782

Speciallægerne på Rolighedsvej
Birkerød, Denmark, 3460
Sponsors and Collaborators
The Specialist Doctors at Rolighedsvej
Danish Medical Association
Surgical Clinic, Allerød, Denmark
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lene Hendel, MD, DMsc, The Specialist Doctors at Rolighedsvej Identifier: NCT01055782     History of Changes
Other Study ID Numbers: H-1-2009-80
Study First Received: January 24, 2010
Results First Received: March 23, 2012
Last Updated: June 6, 2012

Keywords provided by The Specialist Doctors at Rolighedsvej:
Pain perception
Colonoscopy to the coecum (success rate)
Patient's perception of pain
Duration of successful colonoscopies processed this record on April 26, 2017