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Clinical Trials/NCT03808012
NCT03808012WithdrawnNot Applicable

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

University Hospital Tuebingen1 site in 1 countryStarted: April 10, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Braking performance 1

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Braking after inguinal hernia surgery

Experimental

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

Intervention: Braking performance in a brake simulator (Other)

Outcomes

Primary Outcomes

Braking performance 1

Time Frame: measurements will be: preoperatively, 2 days postoperatively

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

Time Frame: measurements will be: preoperatively, 8 days postoperatively

Improvement of Braking performance from preoperatively to 8 days postoperatively in the brake simulator with the focus on brake response time (ms)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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