Simulation-assisted Teaching in Learning Gastroscopy
Sponsor
Anders Bo Nielsen (Other)
Overall Status
Completed
CT.gov ID
NCT04247399
Collaborator
(none)
25
1
2
26.5
0.9
Study Details
Study Description
Brief Summary
This project is a single-blinded randomized controlled trial investigating the effect of simulation-based teaching in learning gastroscopy for medical doctors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Simulation-assisted Teaching in Learning Gastroscopy
Actual Study Start Date
:
Feb 15, 2020
Actual Primary Completion Date
:
Jan 30, 2022
Actual Study Completion Date
:
May 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Simulation-based learning + clinical training
|
Other: Simulation-based learning
Pre-clinical simulation-based learning at Simbionix GI-mentor II virtual reality simulator and OGI CLA 4 phantom.
|
| No Intervention: Clinical training
|
Outcome Measures
Primary Outcome Measures
- Number of procedures before declared unassisted [1 year]
Number of gastroscopies before the supervisor declare the participant ready to do unassisted upper GI endoscopies
Secondary Outcome Measures
- Patient satisfaction [1 year]
Survey using "Gastrointestinal Endoscopy Satisfaction Questionnaire" a validated questionnaire using a scale from 1-5 (5 is the best).
- Complication rate [1 year]
- Mucosa visualization percent of the upper gastrointestinal tract [1 year]
Assessed by endoscopy experts at video documented endoscopies
- Duration of intubation [1 year]
Duration of time that the patient is intubated with the endoscope
- Time [1 year]
Total time for the procedure
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Medical doctors in medical gastroenterology or surgery
Exclusion Criteria:
- prior experience with gastroscopy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Odense University Hospital | Odense | Region Of Southern Denmark | Denmark | 5000 |
Sponsors and Collaborators
- Anders Bo Nielsen
Investigators
- Principal Investigator: Anders Bo Nielsen, MD, Odense University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Anders Bo Nielsen,
Medical Doctor,
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT04247399
Other Study ID Numbers:
- OP_972
First Posted:
Jan 30, 2020
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No