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Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy

NCT ID: NCT00576043

Last Updated: 2008-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2008-03-31

Brief Summary

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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

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Conditions

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Pain

Keywords

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training Patient satisfaction endoscopy simulator Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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1: Training

3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator

Group Type ACTIVE_COMPARATOR

Simulator Training

Intervention Type PROCEDURE

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

2: No Training

No simulator training before starting endoscopy training on real patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gastroenterology and Hepatology, Medical University of Vienna

Principal Investigators

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Arnulf Ferlitsch, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Internal Medicine III, Div. of Gastroenterology and Hepatology, Endoscopy Unit, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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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. doi: 10.1055/s-2002-33456.

Reference Type BACKGROUND
PMID: 12195326 (View on PubMed)

Other Identifiers

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endosim

Identifier Type: -

Identifier Source: org_study_id