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

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ClinicalTrials.gov Identifier: NCT00576043
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : March 27, 2008
Sponsor:
Information provided by:
Medical University of Vienna

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Procedure: Simulator Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy: A Randomized, Controlled Trial
Study Start Date : March 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Patient satisfaction measured on a visual analogue scale (VAS) [ Time Frame: once immediately after patient endoscopy ]

Secondary Outcome Measures :
  1. pain during endoscopy, measured with patient documentation on a visual analogue scale (VAS) [ Time Frame: once immediately after patient endoscopy ]
  2. 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 ]
  3. number of found/missed pathologies [ Time Frame: during endoscopy ]
  4. average time for successful endoscopy [ Time Frame: during endoscopy ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008

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