Education Clinical Trial
Official title:
Simulation-assisted Teaching in Learning Gastroscopy
| 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 |
| Verified date | May 2022 |
| Source | Odense University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This project is a single-blinded randomized controlled trial investigating the effect of simulation-based teaching in learning gastroscopy for medical doctors.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Odense University Hospital | Odense | Region Of Southern Denmark |
| Lead Sponsor | Collaborator |
|---|---|
| Anders Bo Nielsen |
Denmark,
| 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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