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NCT03808012 Clinical Trial

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

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03808012
Other study ID # 001/2019BO2
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 10, 2019
Est. completion date July 30, 2020

Study information
Verified date January 2019
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 30, 2020
Est. primary completion date April 9, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Germany University Hospital Tuebingen, Department of Orthopaedics Tuebingen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) measurements will be: preoperatively, 2 days postoperatively
Primary 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) measurements will be: preoperatively, 8 days postoperatively
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