Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: Simulator Training

• Registration Number: NCT00576043
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-18
• Status Verified: 2008-03
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Last Update Submitted: 2008-03-25
• Last Update Posted: 2008-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Training	Simulator Training	3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator

Primary Outcome Measures

Name	Time	Method
Patient satisfaction measured on a visual analogue scale (VAS)	once immediately after patient endoscopy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Internal Medicine III, Div. of Gastroenterology and Hepatology, Endoscopy Unit, Medical University of Vienna; 🇦🇹 Vienna, Austria