NCT00519129CompletedPhase 3
Magnetic Endoscopic Imaging Versus Standard Colonoscopy in a Routine Colonoscopy Setting: A Randomised Controlled Trial
Sorlandet Hospital HF1 site in 1 country800 target enrollmentStarted: August 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Time used to reach the coecum
Study Overview
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
Detailed Description
Results published in Holme et.al. Gastrointestinal Endoscopy 2011;73:1215-1222.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Time used to reach the coecum
Time Frame: instant
pain during coloscopy
Time Frame: instant
Secondary Outcomes
- coecum-intubation rate(instant)
- Polyp detection rate(instant)
- Pain during the first 24 hours after coloscopy(24 hours)
- level achieved when the coecum can not be reached(instant)
- Need for assistance by a colleague(instant)
- Need for analgetics(instant)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Effect of Magnetic Endoscopic Imaging on Patient Pain During ColonoscopyColonic DiseasesNCT02681692Shanghai Jiao Tong University School of Medicine594
Withdrawn
Not Applicable
The Effect of ScopeGuide on the Mental Workload of EndoscopistAny Symptoms Requiring ColonoscopyNCT02092493University Hospital Southampton NHS Foundation Trust
Recruiting
Not Applicable
Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner EndoscopistsColonic NeoplasmsNCT05746962Korea University Anam Hospital128
Terminated
Not Applicable
The Use of Magnetic Endoscopic Imagers During Colonoscopy for Loop Recognition and ResolutionColonoscopic Surgical ProceduresNCT02109536Lawrence Charles Hookey800
Completed
Not Applicable
The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient ColonoscopyColonoscopyNCT01480830Nova Scotia Health Authority633