NCT04247399

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

February 15, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

December 19, 2019

Last Update Submit

May 30, 2022

Conditions

EndoscopyEducationGastroscopyEsophagogastroduodenoscopySimulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Patient satisfaction

    1 year

  • Complication rate

    1 year

  • Mucosa visualization percent of the upper gastrointestinal tract

    1 year

  • Duration of intubation

    1 year

  • Time

    1 year

Study Arms (2)

Simulation-based learning + clinical training

EXPERIMENTAL
Other: Simulation-based learning

Clinical training

NO INTERVENTION

Interventions

Simulation-based learningOTHER

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

Simulation-based learning + clinical training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical doctors in medical gastroenterology or surgery

You may not qualify if:

  • prior experience with gastroscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

Study Officials

  • Anders Bo Nielsen, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 19, 2019

First Posted

January 30, 2020

Study Start

February 15, 2020

Primary Completion

January 30, 2022

Study Completion

May 1, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations

DK(1)