Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy

Pain Clinical Trial

— endosim  

Official title:

Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy: A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576043
• Other study ID #: endosim
• Status: Completed
• Phase: N/A
• First received: December 17, 2007
• Last updated: March 25, 2008
• Start date: March 2004
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Austria	Internal Medicine III, Div. of Gastroenterology and Hepatology, Endoscopy Unit, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Ferlitsch A, Glauninger P, Gupper A, Schillinger M, Haefner M, Gangl A, Schoefl R. Evaluation of a virtual endoscopy simulator for training in gastrointestinal endoscopy. Endoscopy. 2002 Sep;34(9):698-702. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction measured on a visual analogue scale (VAS)		once immediately after patient endoscopy	No
Secondary	pain during endoscopy, measured with patient documentation on a visual analogue scale (VAS)		once immediately after patient endoscopy	No
Secondary	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)		during endoscopy	No
Secondary	number of found/missed pathologies		during endoscopy	Yes
Secondary	average time for successful endoscopy		during endoscopy	No