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

NCT03808012 | Withdrawn

• 1 other identifier: 001/2019BO2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Braking after inguinal hernia surgery

EXPERIMENTAL

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

Interventions

Braking performance in a brake simulator 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.

Braking after inguinal hernia surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled surgery for inguinal hernia of the right groin with Lichtenstein procedure
• valid driving license
• male and female

You may not qualify if:

• lacking driving license
• pregnancy
• neuromuscular disorder (e.g. myopathy, muscular dystrophy)
• central neurological disorders/diseases (e.g. apoplexia, psychiatric diseases)

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen, Department of Orthopaedics

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulf K Hofmann, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 17, 2019
• Study Start: April 10, 2019
• Primary Completion: April 9, 2020
• Study Completion: July 30, 2020
• Last Updated: December 29, 2020

Record last verified: 2019-01

Locations

DE (1)