Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy

Study Overview
=================
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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: Simulator Training


Participation Criteria
=================
Eligibility 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1: Training<br>3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator | Procedure: Simulator Training<br>* 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<br>|
| No Intervention: 2: No Training<br>No simulator training before starting endoscopy training on real patients | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction measured on a visual analogue scale (VAS) |  | once immediately after patient endoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain during endoscopy, measured with patient documentation on a visual analogue scale (VAS) |  | once immediately after patient endoscopy | 
| 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 | 
| number of found/missed pathologies |  | during endoscopy | 
| average time for successful endoscopy |  | during endoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
training, Patient satisfaction, endoscopy, simulator, Safety