Simulation Efficacy in Neurosurgical Education

NCT ID: NCT02988154

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30

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.

Conditions

Educational; Simulation; Hydrocephalus; Intraventricular Hemorrhage

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Arm A: Simulation training cohort

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.

Simulation training

Intervention Type: OTHER

Simulation training (computer simulation of the procedure, followed by simulation on a dead animal model).

Arm B: ''See one, do one'' cohort

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.

''See one, do one'' approach

Intervention Type: OTHER

The participants watch an experienced surgeon perform the EVD placement, after which the participants attempt to perform the procedure independantly on the skull model.

Interventions

Simulation training

Simulation training (computer simulation of the procedure, followed by simulation on a dead animal model).

Intervention Type: OTHER

''See one, do one'' approach

The participants watch an experienced surgeon perform the EVD placement, after which the participants attempt to perform the procedure independantly on the skull model.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• never performed EVD placements before

Exclusion Criteria

• any surgical experience with EVD placement

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

A. Nimer Amr

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander L Green, MD

Role: STUDY_DIRECTOR

University of Oxford

Locations

University of Mainz / Department of Neurosurgery

Mainz, Rhineland-Palatinate, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Amr Nimer Amr, MD

Role: CONTACT

amr@uni-mainz.de

0049 6131 17 7331

Florian Ringel, MD

Role: CONTACT

florian.ringel@unimedizin-mainz.de

0049 6131 17 7331

Facility Contacts

Amr Nimer Amr

Role: primary

amr@uni-mainz.de

06131 177331

Eleftherios Archavlis, MD

Role: backup

eleftherios.archavlis@unimedizin-mainz.de

06131 177331

Other Identifiers

SimLab_SSP_01

Identifier Type: -

Identifier Source: org_study_id