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Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy (endosim)

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00576043
First received: December 17, 2007
Last updated: March 25, 2008
Last verified: March 2008
History of Changes
  Purpose

Trainees (Residents in internal medicine), naive to real patient endoscopy, will be randomized to receive either 3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator GI-Mentor or no training before starting on-patient endoscopy in the University of Vienna Medical School Endoscopy Unit. Patients satisfaction and pain, technical accuracy and number of found/missed pathologies as well as average time for successful endoscopy will be recorded. After one month or 50 supervised, self performed endoscopies, trainees will be evaluated again with the above mentioned criteria during ten consecutive investigations.


Condition Intervention
Pain
 Procedure: Simulator Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy: A Randomized, Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Patient satisfaction measured on a visual analogue scale (VAS) [ Time Frame: once immediately after patient endoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain during endoscopy, measured with patient documentation on a visual analogue scale (VAS) [ Time Frame: once immediately after patient endoscopy ] [ Designated as safety issue: No ]
  • technical accuracy (oral introduction of the scope into the esophagus, ability of passing the endoscope through the pylorus, inversion of the scope in the gastric fundus) [ Time Frame: during endoscopy ] [ Designated as safety issue: No ]
  • number of found/missed pathologies [ Time Frame: during endoscopy ] [ Designated as safety issue: Yes ]
  • average time for successful endoscopy [ Time Frame: during endoscopy ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2004
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1: Training
3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator
 Procedure: Simulator Training
3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator with the GI-Mentor Virtual simulator device
No Intervention: 2: No Training
No simulator training before starting endoscopy training on real patients

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Trainees: naive to real patient endoscopy before training phase

Exclusion Criteria:

  • Medical doctors with experience in gastrointestinal endoscopy
  • Patients sedated for upper GI endoscopy
  • Patients unwilling or unable to sign informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576043

Locations
Austria
Internal Medicine III, Div. of Gastroenterology and Hepatology, Endoscopy Unit, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Arnulf Ferlitsch, MD Medical University of Vienna
  More Information

Publications:

Responsible Party: Arnulf Ferlitsch, MD, Gastroenterology and Hepatology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00576043     History of Changes
Other Study ID Numbers: endosim
Study First Received: December 17, 2007
Last Updated: March 25, 2008
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
training
Patient satisfaction
endoscopy
simulator
Safety

ClinicalTrials.gov processed this record on May 22, 2013