<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02988154</url>
  </required_header>
  <id_info>
    <org_study_id>SimLab_SSP_01</org_study_id>
    <nct_id>NCT02988154</nct_id>
  </id_info>
  <brief_title>Simulation Efficacy in Neurosurgical Education</brief_title>
  <acronym>SENSE</acronym>
  <official_title>Investigating the Efficacy of Simulation Curricula in Neurosurgical Education</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johannes Gutenberg University Mainz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate the efficacy of simulation in neurosurgical training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to investigate the efficacy of simulation in neurosurgical training. This&#xD;
      will be assessed using accuracy and speed tests in the placement of external ventricle drain&#xD;
      catheters (EVDs). EVD placement is a relatively simple neurosurgical procedure aimed at&#xD;
      inexperienced young trainees.&#xD;
&#xD;
      This study has two arms. The recruits are inexperienced trainees and/or interns and students&#xD;
      who have never performed EVD placements before. The recruits are randomly assigned (using&#xD;
      computer-based randomisation) to either Arm A or Arm B.&#xD;
&#xD;
      Recruits to Arm A undergo simulation training (computer simulation of the procedure, followed&#xD;
      by simulation on a dead animal model), after which the recruits will attempt to perform an&#xD;
      EVD procedure on their own, on a 3D-printed skull model that we designed.&#xD;
&#xD;
      Recruits to Arm B will witness an EVD placement as performed by an experienced surgeon, after&#xD;
      the recruits will attempt to perform an EVD procedure on their own, using the aforementioned&#xD;
      3D-printed skull model. This mimics the ''see one, do one'' paradigm prevalent in surgical&#xD;
      training.&#xD;
&#xD;
      The efficacy of the simulation training will be assessed using the following criteria:&#xD;
&#xD;
      i. Accuracy test:&#xD;
&#xD;
      The accuracy of the catheter placement is assessed in both arms and compared to investigate&#xD;
      whether there is a difference in the accuracy of the catheter placement in both arms.&#xD;
&#xD;
      ii. Speed test:&#xD;
&#xD;
      The speed of catheter placement is assessed in both arms and compared to investigate whether&#xD;
      there is a difference in the speed of the catheter placement in both arms.&#xD;
&#xD;
      iii. Subjective surveys&#xD;
&#xD;
      The researchers will gauge the extent of the trainees' confidence in their surgical skills&#xD;
      and their satisfaction with their training before and after completion of the simulation&#xD;
      training using a questionnaire to be designed for this purpose. The trainees will assess&#xD;
      their own familiarity with and confidence in the procedure using a scale from 0 (&quot;not&#xD;
      familiar with the procedure&quot;, &quot;I have no confidence in being able to perform this procedure&#xD;
      independently&quot;) to 10 (&quot;I am an expert at this procedure&quot;, &quot;I am able to perform this&#xD;
      procedure independently with complete confidence&quot;). This data will be collected and input&#xD;
      into a statistical software (Statistical Lab v. 3, CeDiS) to analyse the difference (if any)&#xD;
      in the trainees' familiarity with the procedures and their confidence in being able to&#xD;
      perform them in both arms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <primary_completion_date type="Anticipated">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of catheter placement</measure>
    <time_frame>immediately upon completion of the procedure</time_frame>
    <description>The placement of the catheter will be analysed by blinded assessors. Outcome: is the catheter in the ventricle (yes/no).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speed of performing the procedure</measure>
    <time_frame>immediately upon completion of the procedure</time_frame>
    <description>The time needed to complete the procedure will be recorded in seconds by blinded assessors.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective survey</measure>
    <time_frame>To be taken immediately before and immediately after performing the EVD insertion</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Educational</condition>
  <condition>Simulation</condition>
  <condition>Hydrocephalus</condition>
  <condition>Intraventricular Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Arm A: Simulation training cohort</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: ''See one, do one'' cohort</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simulation training</intervention_name>
    <description>Simulation training (computer simulation of the procedure, followed by simulation on a dead animal model).</description>
    <arm_group_label>Arm A: Simulation training cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>''See one, do one'' approach</intervention_name>
    <description>The participants watch an experienced surgeon perform the EVD placement, after which the participants attempt to perform the procedure independantly on the skull model.</description>
    <arm_group_label>Arm B: ''See one, do one'' cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The recruits to the study are inexperienced surgical trainees and/or interns and students&#xD;
        who have never performed EVD placements before.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  never performed EVD placements before&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any surgical experience with EVD placement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander L Green, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amr Nimer Amr, MD</last_name>
    <phone>0049 6131 17 7331</phone>
    <email>amr@uni-mainz.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Florian Ringel, MD</last_name>
    <phone>0049 6131 17 7331</phone>
    <email>florian.ringel@unimedizin-mainz.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Mainz / Department of Neurosurgery</name>
      <address>
        <city>Mainz</city>
        <state>Rheinland Pfalz</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amr Nimer Amr</last_name>
      <phone>06131 177331</phone>
      <email>amr@uni-mainz.de</email>
    </contact>
    <contact_backup>
      <last_name>Eleftherios Archavlis, MD</last_name>
      <phone>06131 177331</phone>
      <email>eleftherios.archavlis@unimedizin-mainz.de</email>
    </contact_backup>
    <investigator>
      <last_name>Amr Nimer</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eleftherios Archavlis</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation>
    <investigator_full_name>A. Nimer Amr</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>Medical education</keyword>
  <keyword>simulation</keyword>
  <keyword>neurosurgical education</keyword>
  <keyword>Simulation laboratory</keyword>
  <keyword>Ventricular drain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocephalus</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02988154
org study id: SimLab_SSP_01
nct id: NCT02988154
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the efficacy of simulation in neurosurgical training.
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.
observational model: Other
time perspective: Prospective
measure: Accuracy of catheter placement
time frame: immediately upon completion of the procedure
description: The placement of the catheter will be analysed by blinded assessors. Outcome: is the catheter in the ventricle (yes/no).
measure: Speed of performing the procedure
time frame: immediately upon completion of the procedure
description: The time needed to complete the procedure will be recorded in seconds by blinded assessors.
measure: Subjective survey
time frame: To be taken immediately before and immediately after performing the EVD insertion
arm group label: Arm A: Simulation training cohort
description: 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.
arm group label: Arm B: ''See one, do one'' cohort
description: 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.
intervention type: Other
intervention name: Simulation training
description: Simulation training (computer simulation of the procedure, followed by simulation on a dead animal model).
arm group label: Arm A: Simulation training cohort
intervention type: Other
intervention name: ''See one, do one'' approach
description: The participants watch an experienced surgeon perform the EVD placement, after which the participants attempt to perform the procedure independantly on the skull model.
arm group label: Arm B: ''See one, do one'' cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alexander L Green, MD
role: Study Director
affiliation: University of Oxford
last name: Amr Nimer Amr, MD
phone: 0049 6131 17 7331
email: amr@uni-mainz.de
last name: Florian Ringel, MD
phone: 0049 6131 17 7331
email: florian.ringel@unimedizin-mainz.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Johannes Gutenberg University Mainz
investigator full name: A. Nimer Amr
investigator title: Investigator
mesh term: Hydrocephalus
mesh term: Hemorrhage
sharing ipd: No