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

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03808012
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
15.7
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Braking performance in a brake simulator
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia
Actual Study Start Date :
Apr 10, 2019
Anticipated Primary Completion Date :
Apr 9, 2020
Anticipated Study Completion Date :
Jul 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Braking after inguinal hernia surgery

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

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.

Outcome Measures

Primary Outcome Measures

  1. Braking performance 1 [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)

  2. Braking performance 2 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Tuebingen, Department of Orthopaedics Tuebingen Germany 72076

Sponsors and Collaborators

  • University Hospital Tuebingen

Investigators

  • Principal Investigator: Ulf K Hofmann, MD, University Hospital Tuebingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT03808012
Other Study ID Numbers:
  • 001/2019BO2
First Posted:
Jan 17, 2019
Last Update Posted:
Dec 29, 2020
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Emergencies
Hernia
Hernia, Inguinal

Study Results

No Results Posted as of Dec 29, 2020