Simulation Efficacy in Neurosurgical Education

• Conditions: Simulation; Educational; Intraventricular Hemorrhage; Hydrocephalus
• Interventions: Other: ''See one, do one'' approach; Other: Simulation training

• Registration Number: NCT02988154
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-09
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• never performed EVD placements before

Exclusion Criteria

• any surgical experience with EVD placement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm B: ''See one, do one'' cohort	''See one, do one'' approach	Recruits to Arm B will witness an EVD placement as performed by an experienced surgeon, after which they 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.
Arm A: Simulation training cohort	Simulation training	Recruits to Arm A undergo simulation training (computer simulation of the procedure, followed by simulation on a dead animal model), after which they will attempt to perform an EVD procedure on their own, on a 3D-printed skull model that we designed.

Primary Outcome Measures

Name	Time	Method
Accuracy of catheter placement	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	immediately upon completion of the procedure	The time needed to complete the procedure will be recorded in seconds by blinded assessors.

Secondary Outcome Measures

Name	Time	Method
Subjective survey	To be taken immediately before and immediately after performing the EVD insertion

Trial Locations

Locations (1)

University of Mainz / Department of Neurosurgery; 🇩🇪 Mainz, Rheinland Pfalz, Germany