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Clinical Trials/NCT02988154
NCT02988154UnknownNot Applicable

Investigating the Efficacy of Simulation Curricula in Neurosurgical Education

Johannes Gutenberg University Mainz1 site in 1 country20 target enrollmentStarted: June 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Accuracy of catheter placement

Study Overview

Brief Summary

This study aims to investigate the efficacy of simulation in neurosurgical training.

Detailed Description

This study aims to investigate the efficacy of simulation in neurosurgical training. This will be assessed using accuracy and speed tests in the placement of external ventricle drain catheters (EVDs). EVD placement is a relatively simple neurosurgical procedure aimed at inexperienced young trainees.

This study has two arms. The recruits are inexperienced trainees and/or interns and students who have never performed EVD placements before. The recruits are randomly assigned (using computer-based randomisation) to either Arm A or Arm B.

Recruits to Arm A undergo simulation training (computer simulation of the procedure, followed by simulation on a dead animal model), after which the recruits will attempt to perform an EVD procedure on their own, on a 3D-printed skull model that we designed.

Recruits to Arm B will witness an EVD placement as performed by an experienced surgeon, after the recruits will attempt to perform an EVD procedure on their own, using the aforementioned 3D-printed skull model. This mimics the ''see one, do one'' paradigm prevalent in surgical training.

The efficacy of the simulation training will be assessed using the following criteria:

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • never performed EVD placements before

Exclusion Criteria

  • any surgical experience with EVD placement

Outcomes

Primary Outcomes

Accuracy of catheter placement

Time Frame: immediately upon completion of the procedure

The placement of the catheter will be analysed by blinded assessors. Outcome: is the catheter in the ventricle (yes/no).

Speed of performing the procedure

Time Frame: immediately upon completion of the procedure

The time needed to complete the procedure will be recorded in seconds by blinded assessors.

Secondary Outcomes

  • Subjective survey(To be taken immediately before and immediately after performing the EVD insertion)

Investigators

Sponsor
Johannes Gutenberg University Mainz
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

A. Nimer Amr

Investigator

Johannes Gutenberg University Mainz

Study Sites (1)

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