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OpenTrials
Completed

NCT Number: NCT04247399

Simulation-assisted Teaching in Learning Gastroscopy

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

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Key information

Conditions

Endoscopy Education Esophagogastroduodenoscopy Gastroscopy Simulation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medical doctors in medical gastroenterology or surgery

Exclusion criteria

  • prior experience with gastroscopy

Treatment and study plan

Simulation-based learning

Other

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

Primary outcomes

  1. Number of procedures before declared unassisted

    Time frame: 1 year

    Number of gastroscopies before the supervisor declare the participant ready to do unassisted upper GI endoscopies

Secondary outcomes

  1. Patient satisfaction

    Time frame: 1 year

    Survey using "Gastrointestinal Endoscopy Satisfaction Questionnaire" a validated questionnaire using a scale from 1-5 (5 is the best).

  2. Complication rate

    Time frame: 1 year

  3. Mucosa visualization percent of the upper gastrointestinal tract

    Time frame: 1 year

    Assessed by endoscopy experts at video documented endoscopies

  4. Duration of intubation

    Time frame: 1 year

    Duration of time that the patient is intubated with the endoscope

  5. Time

    Time frame: 1 year

    Total time for the procedure

Sponsors and collaborators

Lead sponsor

Anders Bo Nielsen

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 30, 2020
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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