Colonoscopy Endoguide in Specialist Practice

This study has been completed.
Sponsor:
Collaborators:
A foundation of th Danish Association of Medical Specialists
Surgical Clinic, Allerød, Denmark
Information provided by (Responsible Party):
Lene Hendel, The Specialist Doctors at Rolighedsvej
ClinicalTrials.gov Identifier:
NCT01055782
First received: January 24, 2010
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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
Colonoscopy
Pain
Device: Endoguide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perception of Pain [ Time Frame: After endoscopy (within 10mins) and 1 day after endoscopy ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent provided

Exclusion Criteria:

  • Informed consent not provided or not possible to obtain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055782

Locations
Denmark
Speciallægerne på Rolighedsvej
Birkerød, Denmark, 3460
Sponsors and Collaborators
The Specialist Doctors at Rolighedsvej
A foundation of th Danish Association of Medical Specialists
Surgical Clinic, Allerød, Denmark
  More Information

No publications provided by The Specialist Doctors at Rolighedsvej

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lene Hendel, MD, DMsc, The Specialist Doctors at Rolighedsvej
ClinicalTrials.gov 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
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by The Specialist Doctors at Rolighedsvej:
Colonoscopy
Endoguide
Pain perception
Colonoscopy to the coecum (success rate)
Patient's perception of pain
Duration of successful colonoscopies

ClinicalTrials.gov processed this record on October 21, 2014