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NCT04247399 Clinical Trial

Simulation-assisted Teaching in Learning Gastroscopy

Education Clinical Trial

Official title:
Simulation-assisted Teaching in Learning Gastroscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04247399
Other study ID # OP_972
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2020
Est. completion date May 1, 2022

Study information
Verified date May 2022
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project is a single-blinded randomized controlled trial investigating the effect of simulation-based teaching in learning gastroscopy for medical doctors.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date May 1, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Medical doctors in medical gastroenterology or surgery Exclusion Criteria: - prior experience with gastroscopy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Simulation-based learning
Pre-clinical simulation-based learning at Simbionix GI-mentor II virtual reality simulator and OGI CLA 4 phantom.

Locations
Country Name City State
Denmark Odense University Hospital Odense Region Of Southern Denmark

Sponsors (1)
Lead Sponsor Collaborator
Anders Bo Nielsen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of procedures before declared unassisted Number of gastroscopies before the supervisor declare the participant ready to do unassisted upper GI endoscopies 1 year
Secondary Patient satisfaction Survey using "Gastrointestinal Endoscopy Satisfaction Questionnaire" a validated questionnaire using a scale from 1-5 (5 is the best). 1 year
Secondary Complication rate 1 year
Secondary Mucosa visualization percent of the upper gastrointestinal tract Assessed by endoscopy experts at video documented endoscopies 1 year
Secondary Duration of intubation Duration of time that the patient is intubated with the endoscope 1 year
Secondary Time Total time for the procedure 1 year
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