Colonoscopy Endoguide in Specialist Practice
This study has been completed.
Sponsor:
The Specialist Doctors at Rolighedsvej
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
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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
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
| 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 May 19, 2013