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

NCT ID: NCT03808012

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-10

Study Completion Date

2020-07-30

Brief Summary

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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).

Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Braking after inguinal hernia surgery

Cohort testing of driving performance in a brake simulator in patients before and after scheduled inguinal hernia surgery

Group Type EXPERIMENTAL

Braking performance in a brake simulator

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulf K Hofmann, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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University Hospital Tuebingen, Department of Orthopaedics

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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001/2019BO2

Identifier Type: -

Identifier Source: org_study_id