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NCT04150237 Clinical Trial

Using Simulation to Ensure Basic Competence in Gastroscopy

Education Clinical Trial

Official title:
Using Simulation to Ensure Basic Competence in Gastroscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04150237
Other study ID # OP_971
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date January 1, 2020

Study information
Verified date September 2021
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main purpose of this study is to develop and gather validity evidence for a simulation-based test to ensure learning basic competence in gastroscopy.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date January 1, 2020
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Medical students enrolled at the University of Southern Denmark who have passed their anatomy exam. - Experienced endoscopy nurses, who have assisted to more than 100 gastroscopies and with no prior self-performed gastroscopies. - Experienced medical doctors in medical gastroenterology or surgery, who have self-performed more than 500 gastroscopies. Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Simulation training in gastroscopy
Simulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom.

Locations
Country Name City State
Denmark Odense University Hospital Odense

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Simulation gastroscopy test score Test score based on time usage, landmark and pathology recognition 1-hour test
Secondary Total time for the diagnostic exercises A total time for two diagnostic virtual reality tests and a test on a phantom 1-hour test
Secondary Total time for the tool exercises A total time of virtual reality tests and two tests on a phantom 1-hour test
Secondary Total landmark and pathology recognition for the diagnostic exercises Recognition of a total number of 48 landmarks and pathologies 1-hour test
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