endosim: Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT00576043
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Mar 1, 2004
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patient satisfaction measured on a visual analogue scale (VAS) [once immediately after patient endoscopy]

Secondary Outcome Measures

1. pain during endoscopy, measured with patient documentation on a visual analogue scale (VAS) [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) [during endoscopy]

3. number of found/missed pathologies [during endoscopy]

4. average time for successful endoscopy [during endoscopy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00576043
• Other Study ID Numbers: endosim
• First Posted: Dec 18, 2007
• Last Update Posted: Mar 27, 2008
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: training; Patient satisfaction; endoscopy; simulator; Safety

Study Results

No Results Posted as of Mar 27, 2008