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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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)

Related Conditions & MeSH terms

• Emergencies
• Hernia
• Hernia, Inguinal
• Inguinal Hernia

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