Incisional HerniaVAGSINCT02321059
Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia
An observational study of Incisional Hernia, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Patients with an incisional hernia in the midline and controls with an intact abdominal wall are examined twice with one week apart, in order to establish the test-retest reliability and internal and external validity of the Goodstrength trunk dynamometer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Measurement of abdominal wall strength
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Jun 2015
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients on waiting list for repair of a ventral incisional hernia and healthy volunteers.
Who may be able to join
- American Society of Anesthesiologists score 1-3
- Age equal to or above 18
- Ventral incisional hernia OR intact abdominal wall
Who cannot join
- Pregnancy
- Severe heart disease (New York Heart Association class III-IV)
- Severe pulmonary disease
- Severe musculoskeletal disease
- Systemic treatment with glucocorticoid
Trial locations and contacts
1 site in 1 country.
About this study
Patients with an incisional hernia in the midline and controls with an intact abdominal wall are examined twice with one week apart, in order to establish the test-retest reliability and internal and external validity of the Goodstrength trunk dynamometer.
- Conditions
- Incisional Hernia
- Being tested
- Measurement of abdominal wall strength
- Keywords
- incisional hernia, hernia, abdominal wall strength, validation, physical activity
- Medical subject headings
- Incisional Hernia, Hernia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of abdominal wall strengthDevice
Test-retest examination of the reliability of the Goodstrength trunk dynamometer
| Study group | Role | What they receive |
|---|---|---|
| No incisional hernia group | Healthy volunteers with an intact abdominal wall. Receives: Device: Measurement of abdominal wall strength | |
| Incisional hernia group | Patients with a ventral incisional hernia. Receives: Device: Measurement of abdominal wall strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal wall strength measured by the Goodstrength system
Change in abdominal wall strength from baseline to follow-up.
Measured: One week
Secondary outcomes (3)
Physical activity the last week, assessed by the International Physical Activity Questionnaire
Measured: Once, at baseline examination
Self-assessed abdominal wall strength, as measured on a visual analogue scale
Measured: Once, at baseline examination
Trunk extensor strength measured by the Goodstrength system
Change in trunk extensor strength from baseline to follow-up.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristian Kiim Jensen, Bispebjerg Hospital
- Investigators
- Kristian K Jensen, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321059
- Sponsor's protocol ID
- H-1-2014-008
- Acronym
- VAGSI
- Status last verified
- Jun 2015
- First submitted
- 11 Nov 2014
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia
- ClinicalTrials.gov ID
- NCT02321059
- Acronym / sponsor ID
- VAGSI / H-1-2014-008
- Conditions
- Incisional Hernia
- Keywords
- incisional hernia, hernia, abdominal wall strength, validation, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Dec 2014 (estimated)
- 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.
Patients with an incisional hernia in the midline and controls with an intact abdominal wall are examined twice with one week apart, in order to establish the test-retest reliability and internal and external validity of the Goodstrength trunk dynamometer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No incisional hernia group | – | Device: Measurement of abdominal wall strengthHealthy volunteers with an intact abdominal wall. |
| Incisional hernia group | – | Device: Measurement of abdominal wall strengthPatients with a ventral incisional hernia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on waiting list for repair of a ventral incisional hernia and healthy volunteers.
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists score 1-3
- Age equal to or above 18
- Ventral incisional hernia OR intact abdominal wall
Key exclusion criteria (5 listed)
- Pregnancy
- Severe heart disease (New York Heart Association class III-IV)
- Severe pulmonary disease
- Severe musculoskeletal disease
- Systemic treatment with glucocorticoid
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 |
|---|---|---|
| Measurement of abdominal wall strengthTest-retest examination of the reliability of the Goodstrength trunk dynamometer | Device | Incisional hernia group, No incisional hernia group |
Primary outcome
Abdominal wall strength measured by the Goodstrength system
Time frame: One week
Change in abdominal wall strength from baseline to follow-up.
3 secondary outcomes
Physical activity the last week, assessed by the International Physical Activity Questionnaire
Time frame: Once, at baseline examination
Self-assessed abdominal wall strength, as measured on a visual analogue scale
Time frame: Once, at baseline examination
Trunk extensor strength measured by the Goodstrength system
Time frame: One week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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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.
Kristian K Jensen, MD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia, run by Bispebjerg Hospital at 1 site in Denmark.
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 5 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: finished, as of the sponsor's last update on 26 Jun 2015. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Abdominal wall strength measured by the Goodstrength system (time frame: One week). 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 26 Jun 2015.