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Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia

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ClinicalTrials.gov Identifier: NCT03808012
Recruitment Status : Withdrawn (Unsuccessful recruitment)
First Posted : January 17, 2019
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Inguinal Hernia Other: Braking performance in a brake simulator Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : April 9, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Braking after inguinal hernia surgery
Cohort testing of driving performance in a brake simulator in patients before and after scheduled inguinal hernia surgery
 Other: Braking performance in a brake simulator
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.


Outcome Measures
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Primary Outcome Measures :
  1. Braking performance 1 [ Time Frame: measurements will be: preoperatively, 2 days postoperatively ]
    Improvement of Braking performance from preoperatively to 2 days postoperatively in the brake simulator with the focus on brake response time (ms)

  2. Braking performance 2 [ Time Frame: measurements will be: preoperatively, 8 days postoperatively ]
    Improvement of Braking performance from preoperatively to 8 days postoperatively in the brake simulator with the focus on brake response time (ms)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled surgery for inguinal hernia of the right groin with Lichtenstein procedure
  • valid driving license
  • male and female

Exclusion Criteria:

  • lacking driving license
  • pregnancy
  • neuromuscular disorder (e.g. myopathy, muscular dystrophy)
  • central neurological disorders/diseases (e.g. apoplexia, psychiatric diseases)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808012


Locations
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Germany
University Hospital Tuebingen, Department of Orthopaedics
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Ulf K Hofmann, MD University Hospital Tuebingen
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03808012    
Other Study ID Numbers: 001/2019BO2
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Hernia
Hernia, Inguinal
Disease Attributes
 Pathologic Processes
Pathological Conditions, Anatomical
Hernia, Abdominal