Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia
Primary Purpose
Inguinal Hernia
Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Braking performance in a brake simulator
Sponsored by
About this trial
This is an interventional diagnostic trial for Inguinal Hernia
Eligibility 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)
Sites / Locations
- University Hospital Tuebingen, Department of Orthopaedics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Braking after inguinal hernia surgery
Arm Description
Cohort testing of driving performance in a brake simulator in patients before and after scheduled inguinal hernia surgery
Outcomes
Primary Outcome Measures
Braking performance 1
Improvement of Braking performance from preoperatively to 2 days postoperatively in the brake simulator with the focus on brake response time (ms)
Braking performance 2
Improvement of Braking performance from preoperatively to 8 days postoperatively in the brake simulator with the focus on brake response time (ms)
Secondary Outcome Measures
Full Information
NCT ID
NCT03808012
First Posted
January 14, 2019
Last Updated
December 28, 2020
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT03808012
Brief Title
Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia
Official Title
Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Unsuccessful recruitment
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
April 9, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Braking after inguinal hernia surgery
Arm Type
Experimental
Arm Description
Cohort testing of driving performance in a brake simulator in patients before and after scheduled inguinal hernia surgery
Intervention Type
Other
Intervention Name(s)
Braking performance in a brake simulator
Intervention 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.
Primary Outcome Measure Information:
Title
Braking performance 1
Description
Improvement of Braking performance from preoperatively to 2 days postoperatively in the brake simulator with the focus on brake response time (ms)
Time Frame
measurements will be: preoperatively, 2 days postoperatively
Title
Braking performance 2
Description
Improvement of Braking performance from preoperatively to 8 days postoperatively in the brake simulator with the focus on brake response time (ms)
Time Frame
measurements will be: preoperatively, 8 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf K Hofmann, MD
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Tuebingen, Department of Orthopaedics
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia
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