Text Size

Improving Quality of Colonoscopy Using a 3D-imager

This study has been completed.
Sponsor:
Information provided by:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT00519129
First received: August 21, 2007
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Pain During Colonoscopy
 Device: 3D-imager
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Magnetic Endoscopic Imaging Versus Standard Colonoscopy in a Routine Colonoscopy Setting: A Randomised Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • pain during coloscopy [ Time Frame: instant ] [ Designated as safety issue: No ]
  • Time used to reach the coecum [ Time Frame: instant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • coecum-intubation rate [ Time Frame: instant ] [ Designated as safety issue: No ]
  • level achieved when the coecum can not be reached [ Time Frame: instant ] [ Designated as safety issue: No ]
  • Need for assistance by a colleague [ Time Frame: instant ] [ Designated as safety issue: No ]
  • Need for analgetics [ Time Frame: instant ] [ Designated as safety issue: No ]
  • Pain during the first 24 hours after coloscopy [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Polyp detection rate [ Time Frame: instant ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: August 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: 3D-imager
    3D-imager vs fluoroscopy during coloscopy
    Other Name: Skopguide
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519129

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

No publications provided by Sorlandet Hospital HF

Additional 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
Study First Received: August 21, 2007
Last Updated: August 17, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Sorlandet Hospital HF:
Pain
Patient satisfaction

ClinicalTrials.gov processed this record on May 23, 2013