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Improving Quality of Colonoscopy Using a 3D-imager

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ClinicalTrials.gov Identifier: NCT00519129
Recruitment Status : Completed
First Posted : August 22, 2007
Last Update Posted : August 18, 2011
Sponsor:
Information provided by:
Sorlandet Hospital HF

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Pain During Colonoscopy Device: 3D-imager Phase 3

Detailed Description:
Results published in Holme et.al. Gastrointestinal Endoscopy 2011;73:1215-1222.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Magnetic Endoscopic Imaging Versus Standard Colonoscopy in a Routine Colonoscopy Setting: A Randomised Controlled Trial
Study Start Date : August 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy


Intervention Details:
  • Device: 3D-imager
    3D-imager vs fluoroscopy during coloscopy
    Other Name: Skopguide


Primary Outcome Measures :
  1. pain during coloscopy [ Time Frame: instant ]
  2. Time used to reach the coecum [ Time Frame: instant ]

Secondary Outcome Measures :
  1. coecum-intubation rate [ Time Frame: instant ]
  2. level achieved when the coecum can not be reached [ Time Frame: instant ]
  3. Need for assistance by a colleague [ Time Frame: instant ]
  4. Need for analgetics [ Time Frame: instant ]
  5. Pain during the first 24 hours after coloscopy [ Time Frame: 24 hours ]
  6. Polyp detection rate [ Time Frame: instant ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519129


Locations
Norway
Sorlandet Sykehus HF
Kristiansand, Norway
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Study Director: Geir S Hoff, PhD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00519129     History of Changes
Other Study ID Numbers: SSHF-Colon-1
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: August 18, 2011
Last Verified: August 2011

Keywords provided by Sorlandet Hospital HF:
Pain
Patient satisfaction