Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy

Phase 4

Completed

• Conditions: Any Symptom Requiring Colonoscopy

• Registration Number: NCT00258531
• Lead Sponsor: Sykehuset Telemark

Brief Summary

* A commercial 3-dimentional magnetic imaging system (Olympus ScopeGuide) is available for routine use during colonoscopy.

* No randomised trials have been performed to evaluate if, and to what extent, the use of this technology may improve the coecal intubation rate and reduce the patient's experience of discomfort and pain by making the insertion of the endoscope easier

Detailed Description

Endoscopist at different level of experience are to participate. Patients routinely referred to the outpatients department for colonoscopy are asked to participate in a randomised trial where coecal intubation rate and pain experienced by the patient are end-point. Written informed consent is obtained. For each endoscopist, allocated patients are randomised to colonoscopy with no imaging technique (usual care) or using the 3-dimentional imager.

Study Timeline

• Study Start: 2003-06
• Status Verified: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-11-22
• Study First Submitted QC: 2005-11-22
• Study First Posted: 2005-11-24
• Last Update Submitted: 2006-07-27
• Last Update Posted: 2006-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• A successive series of patients referred for routine colonoscopy

Exclusion Criteria

• Age under 18 years
• Pregnant women
• Persons with pacemaker
• Unwillingness to restrict sedation to "on demand"
• Inability to understand the information given

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pain experienced during colonoscopy

Secondary Outcome Measures

Name	Time	Method
Coecal intubation rate

Trial Locations

Locations (1)

Medical Outpatients dept, Sykehuset Telemark; 🇳🇴 Skien, Norway