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
  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:


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
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: 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 July 10, 2014