Clinical trial NCT02988154: Simulation Efficacy in Neurosurgical Education
Official title: Investigating the Efficacy of Simulation Curricula in Neurosurgical Education
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Educational
Simulation
Hydrocephalus
Intraventricular Hemorrhage
Keywords: Medical education
simulation
neurosurgical education
Simulation laboratory
Ventricular drain
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2016-12-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The recruits to the study are inexperienced surgical trainees and/or interns and students who have never performed EVD placements before.

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:

i. Accuracy test:

The accuracy of the catheter placement is assessed in both arms and compared to investigate whether there is a difference in the accuracy of the catheter placement in both arms.

ii. Speed test:

The speed of catheter placement is assessed in both arms and compared to investigate whether there is a difference in the speed of the catheter placement in both arms.

iii. Subjective surveys

The researchers will gauge the extent of the trainees' confidence in their surgical skills and their satisfaction with their training before and after completion of the simulation training using a questionnaire to be designed for this purpose. The trainees will assess their own familiarity with and confidence in the procedure using a scale from 0 ("not familiar with the procedure", "I have no confidence in being able to perform this procedure independently") to 10 ("I am an expert at this procedure", "I am able to perform this procedure independently with complete confidence"). This data will be collected and input into a statistical software (Statistical Lab v. 3, CeDiS) to analyse the difference (if any) in the trainees' familiarity with the procedures and their confidence in being able to perform them in both arms.

Eligibility criteria: Inclusion Criteria:

* never performed EVD placements before

Exclusion Criteria:

* any surgical experience with EVD placement

Primary outcomes:
measure: Accuracy of catheter placement
timeFrame: immediately upon completion of the procedure
measure: Speed of performing the procedure
timeFrame: immediately upon completion of the procedure
Secondary outcomes:
measure: Subjective survey
timeFrame: To be taken immediately before and immediately after performing the EVD insertion
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University of Mainz / Department of Neurosurgery
state: Rheinland Pfalz
Study officials:
affiliation: University of Oxford
name: Alexander L Green, MD
role: STUDY_DIRECTOR
References: