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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Withdrawn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
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inguinal Hernia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 14, 2019
Last Updated
December 28, 2020
Sponsor
University Hospital Tuebingen
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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Withdrawn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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