Ventral Incisional HerniaNCT03043079
Ultrasound Assessment of Ventral Hernia Defects
A study testing Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity in people with Ventral Incisional Hernia, run by University of Pennsylvania at 1 site in United States.
Trial summary
Quantitative radiographic imaging holds promise as a novel and innovative strategy to assess ventral hernia patients. Assessing abdominal wall changes surrounding ventral hernia using shear wave velocity values measured with ultrasound will identify features of the abdominal wall that differ between healthy volunteers… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventral Incisional Hernia
- What is being tested?
- Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 15 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female between 20-70 years of age
- healthy volunteer or seeking elective ventral hernia repair
Who cannot join
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19146
About this study
Quantitative radiographic imaging holds promise as a novel and innovative strategy to assess ventral hernia patients. Assessing abdominal wall changes surrounding ventral hernia using shear wave velocity values measured with ultrasound will identify features of the abdominal wall that differ between healthy volunteers and subjects scheduled to have ventral hernia repair. Through the use of ultrasound including shear wave velocity measurements, the abdominal wall of 25 subjects scheduled to have ventral hernia repair will be compared to those of 35 healthy volunteers. The ultrasound measurements will elucidate if ventral hernia affects abdominal wall elasticity and effect surgical outcomes.
Read the detailed description
ARFI-SWV Ultrasound holds promise as an inexpensive, noninvasive, point-of-care diagnostic tool for pre-operatively predicting successful hernia repair. The investigators propose to develop and refine a quantitative ultrasound protocol to measure abdominal wall features suitable for predicting successful closure of the midline fascia. ARFI-SWV ultrasound represents a novel and intriguing modality for real time visualization and characterization of changes in the biomechanical properties of diseased musculoskeletal tissues.
In this study, ARFI-SWV ultrasound is hypothesized to preoperatively measure the stiffness in the lateral abdominal wall as an estimation for mobility during hernia repair. Preoperatively evaluating hernia severity through ARFI-SWV ultrasound will be performed to identify mechanical characteristics of the abdominal musculature to predict success of midline fascial re-approximation in hernia patients. The study proposes to compare ultrasound images and associated shear wave velocity measurements between 35 healthy volunteers and 25 subjects undergoing surgical repair for ventral hernia. Subjects with ventral hernia will undergo imaging no earlier than two weeks prior to elective hernia repair and again postoperatively within six months following repair at a standard followup visit. Statistical analysis will determine if there is a significant difference in the abdominal wall stiffness, represented by the ultrasound shear wave velocity measurements, between the healthy subjects and the subjects with ventral hernia. Further analysis will determine if there is any statistically significant relationship between abdominal wall stiffness of subjects with ventral hernia and surgical outcomes.
- Conditions
- Ventral Incisional Hernia
- Being tested
- Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Acoustic Radiation Forced Impulse Shear Wave VelocityDiagnostic test
Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)
| Study group | Role | What they receive |
|---|---|---|
| Ventral Hernia | Experimental | Twenty-five patients diagnosed with ventral hernia Receives: Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity |
| Healthy Volunteers | Other | Twenty-five volunteers without ventral hernia Receives: Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity |
| Active Health Volunteers | Other | Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity Receives: Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall
Differences in the shear wave velocity measurements in the abdominal wall of healthy and ventral hernia patients
Measured: study intiation ultrasound scan lasting up to 45 minutes
Secondary outcomes (2)
Difference in Shear Wave Velocity Measurement in the Abdominal Wall Pre and Post Hernia Repair
Differences in the shear wave velocity measurements in the abdominal wall of preoperative hernia scan and postoperative scan 26 weeks after surgical ventral hernia repair
Measured: through study completion, an up to 26 weeks postoperative
Incidental Findings and Ultrasound Safety
Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startApr 2016
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventral Incisional HerniaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Fischer, MD, MPH, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043079
- Sponsor's protocol ID
- 823896
- Status last verified
- Mar 2020
- First submitted
- 24 Jan 2017
- Last updated
- 24 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data to outside researchers at the end of the study. Any data shared will be de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Ventral Hernia Defects
- ClinicalTrials.gov ID
- NCT03043079
- Acronym / sponsor ID
- 823896
- Conditions
- Ventral Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Posted 24 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Quantitative radiographic imaging holds promise as a novel and innovative strategy to assess ventral hernia patients. Assessing abdominal wall changes surrounding ventral hernia using shear wave velocity values measured with ultrasound will identify features of the abdominal wall that differ between healthy volunteers and subjects scheduled to have ventral hernia repair. Through the use of ultrasound including shear wave velocity measurements, the abdominal wall of 25 subjects scheduled to have ventral hernia repair will be compared to those of 35 healthy volunteers. The ultrasound measurements will elucidate if ventral hernia affects abdominal wall elasticity and effect surgical outcomes.
Detailed description
ARFI-SWV Ultrasound holds promise as an inexpensive, noninvasive, point-of-care diagnostic tool for pre-operatively predicting successful hernia repair. The investigators propose to develop and refine a quantitative ultrasound protocol to measure abdominal wall features suitable for predicting successful closure of the midline fascia. ARFI-SWV ultrasound represents a novel and intriguing modality for real time visualization and characterization of changes in the biomechanical properties of diseased musculoskeletal tissues.
In this study, ARFI-SWV ultrasound is hypothesized to preoperatively measure the stiffness in the lateral abdominal wall as an estimation for mobility during hernia repair. Preoperatively evaluating hernia severity through ARFI-SWV ultrasound will be performed to identify mechanical characteristics of the abdominal musculature to predict success of midline fascial re-approximation in hernia patients. The study proposes to compare ultrasound images and associated shear wave velocity measurements between 35 healthy volunteers and 25 subjects undergoing surgical repair for ventral hernia. Subjects with ventral hernia will undergo imaging no earlier than two weeks prior to elective hernia repair and again postoperatively within six months following repair at a standard followup visit. Statistical analysis will determine if there is a significant difference in the abdominal wall stiffness, represented by the ultrasound shear wave velocity measurements, between the healthy subjects and the subjects with ventral hernia. Further analysis will determine if there is any statistically significant relationship between abdominal wall stiffness of subjects with ventral hernia and surgical outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ventral Hernia | Experimental | Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave VelocityTwenty-five patients diagnosed with ventral hernia |
| Healthy Volunteers | Other | Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave VelocityTwenty-five volunteers without ventral hernia |
| Active Health Volunteers | Other | Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave VelocityTen healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male or female between 20-70 years of age
- healthy volunteer or seeking elective ventral hernia repair
Key exclusion criteria (1 listed)
- pregnant women
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 |
|---|---|---|
| Ultrasound Acoustic Radiation Forced Impulse Shear Wave VelocityAbdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) | Diagnostic test | Active Health Volunteers, Healthy Volunteers, Ventral Hernia |
Primary outcome
Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall
Time frame: study intiation ultrasound scan lasting up to 45 minutes
Differences in the shear wave velocity measurements in the abdominal wall of healthy and ventral hernia patients
2 secondary outcomes
Difference in Shear Wave Velocity Measurement in the Abdominal Wall Pre and Post Hernia Repair
Time frame: through study completion, an up to 26 weeks postoperative
Incidental Findings and Ultrasound Safety
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data to outside researchers at the end of the study. Any data shared will be de-identified.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity in people with Ventral Incisional Hernia, run by University of Pennsylvania at 1 site in United States.
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 2 inclusion and 1 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 24 Mar 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall (time frame: study intiation ultrasound scan lasting up to 45 minutes). 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 24 Mar 2020.