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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Education
• Endoscopy
• Gastroscopy
• Simulation

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