<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/NCT03808012</url>
  </required_header>
  <id_info>
    <org_study_id>001/2019BO2</org_study_id>
    <nct_id>NCT03808012</nct_id>
  </id_info>
  <brief_title>Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia</brief_title>
  <official_title>Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</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>
      Several studies exist on patient performance in drive simulators especially around and after&#xD;
      surgery. Recommendations concerning the ability to drive after inguinal hernia are scarce and&#xD;
      so far do not offer conclusive results. Aim of the study is to analyse reaction time and foot&#xD;
      transfer time (together brake response time) and brake force in a brake simulator before and&#xD;
      after scheduled inguinal hernia surgery (Liechtenstein procedure).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unsuccessful recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">April 10, 2019</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">April 9, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Braking performance 1</measure>
    <time_frame>measurements will be: preoperatively, 2 days postoperatively</time_frame>
    <description>Improvement of Braking performance from preoperatively to 2 days postoperatively in the brake simulator with the focus on brake response time (ms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Braking performance 2</measure>
    <time_frame>measurements will be: preoperatively, 8 days postoperatively</time_frame>
    <description>Improvement of Braking performance from preoperatively to 8 days postoperatively in the brake simulator with the focus on brake response time (ms)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>Braking after inguinal hernia surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort testing of driving performance in a brake simulator in patients before and after scheduled inguinal hernia surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Braking performance in a brake simulator</intervention_name>
    <description>Braking performance is tested in a real middle size car cabin to simulate ergonomic conditions of driving a car. This testing cabin has been equipped with customised equipment to allow measurement of reaction time, foot transfer time, brake response time and brake force.</description>
    <arm_group_label>Braking after inguinal hernia surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled surgery for inguinal hernia of the right groin with Lichtenstein procedure&#xD;
&#xD;
          -  valid driving license&#xD;
&#xD;
          -  male and female&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lacking driving license&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  neuromuscular disorder (e.g. myopathy, muscular dystrophy)&#xD;
&#xD;
          -  central neurological disorders/diseases (e.g. apoplexia, psychiatric diseases)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulf K Hofmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Tuebingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Tuebingen, Department of Orthopaedics</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>December 28, 2020</last_update_submitted>
  <last_update_submitted_qc>December 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03808012
org study id: 001/2019BO2
nct id: NCT03808012
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Several studies exist on patient performance in drive simulators especially around and after
      surgery. Recommendations concerning the ability to drive after inguinal hernia are scarce and
      so far do not offer conclusive results. Aim of the study is to analyse reaction time and foot
      transfer time (together brake response time) and brake force in a brake simulator before and
      after scheduled inguinal hernia surgery (Liechtenstein procedure).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Braking performance 1
time frame: measurements will be: preoperatively, 2 days postoperatively
description: Improvement of Braking performance from preoperatively to 2 days postoperatively in the brake simulator with the focus on brake response time (ms)
measure: Braking performance 2
time frame: measurements will be: preoperatively, 8 days postoperatively
description: Improvement of Braking performance from preoperatively to 8 days postoperatively in the brake simulator with the focus on brake response time (ms)
arm group label: Braking after inguinal hernia surgery
arm group type: Experimental
description: Cohort testing of driving performance in a brake simulator in patients before and after scheduled inguinal hernia surgery
intervention type: Other
intervention name: Braking performance in a brake simulator
description: Braking performance is tested in a real middle size car cabin to simulate ergonomic conditions of driving a car. This testing cabin has been equipped with customised equipment to allow measurement of reaction time, foot transfer time, brake response time and brake force.
arm group label: Braking after inguinal hernia surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ulf K Hofmann, MD
role: Principal Investigator
affiliation: University Hospital Tuebingen
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Hernia
mesh term: Hernia, Inguinal
sharing ipd: Undecided