Inguinal HerniaNCT03808012
Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia
A study testing Braking performance in a brake simulator in people with Inguinal Hernia, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Braking performance in a brake simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 10 Apr 2019to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled surgery for inguinal hernia of the right groin with Lichtenstein procedure
- valid driving license
- male and female
Who cannot join
- lacking driving license
- pregnancy
- neuromuscular disorder (e.g. myopathy, muscular dystrophy)
- central neurological disorders/diseases (e.g. apoplexia, psychiatric diseases)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tuebingen, Department of Orthopaedics
Tübingen, 72076
About this study
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
- Being tested
- Braking performance in a brake simulator
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Braking performance in a brake simulatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Braking after inguinal hernia surgery | Experimental | Cohort testing of driving performance in a brake simulator in patients before and after scheduled inguinal hernia surgery Receives: Other: Braking performance in a brake simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: measurements will be: preoperatively, 8 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start10 Apr 2019
- Primary completion9 Apr 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Why it stopped: Unsuccessful recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulf K Hofmann, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808012
- Sponsor's protocol ID
- 001/2019BO2
- Status last verified
- Jan 2019
- First submitted
- 14 Jan 2019
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia
- ClinicalTrials.gov ID
- NCT03808012
- Acronym / sponsor ID
- 001/2019BO2
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unsuccessful recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 9 Apr 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Braking after inguinal hernia surgery | Experimental | Other: Braking performance in a brake simulatorCohort testing of driving performance in a brake simulator in patients before and after scheduled inguinal hernia surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- scheduled surgery for inguinal hernia of the right groin with Lichtenstein procedure
- valid driving license
- male and female
Key exclusion criteria (4 listed)
- lacking driving license
- pregnancy
- neuromuscular disorder (e.g. myopathy, muscular dystrophy)
- central neurological disorders/diseases (e.g. apoplexia, psychiatric diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Braking performance in a brake simulatorBraking 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. | Other | Braking after inguinal hernia surgery |
Primary outcome
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf K Hofmann, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Braking performance in a brake simulator in people with Inguinal Hernia, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Braking performance 1 (time frame: measurements will be: preoperatively, 2 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.