Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventral Hernia | Experimental | Twenty-five patients diagnosed with ventral hernia |
|
| Healthy Volunteers | Other | Twenty-five volunteers without ventral hernia |
|
| Active Health Volunteers | Other | Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity | Diagnostic Test | Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | study intiation ultrasound scan lasting up to 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an up to 26 weeks postoperative |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19146 | United States |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ventral Hernia | Twenty-One patients diagnosed with ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) |
| FG001 | Healthy Volunteers | Fourteen volunteers without ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) |
| FG002 | Active Health Volunteers | Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Demographic data and shear wave velocity measurements were taken from each subject
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ventral Hernia | Twenty-one patients diagnosed with ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) |
| BG001 | Healthy Volunteers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 21 ventral hernia age and BMI matched to 14 health volunteers with 10 active volunteers | Posted | Mean | Standard Deviation | meters per second | study intiation ultrasound scan lasting up to 45 minutes |
|
Hernia patients were followed for adverse events for an average of 12 months. There were seen in the outpatuent clinic following typical standard of care guidelines, which is typically 2 weeks and 3 months. Healthy and active volunteers were followed during the initial ultrasound, up to 45 minutes.
Adverse events were defined as any event that harmed subjects related to the study protocol. Adverse events related to the hernia surgery itself were not included in the study adverse events as the surgery plan was not affected by study participation. All subjects got the same surgical care that they would have if they were not enrolled in the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ventral Hernia | Twenty-one patients diagnosed with ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) No adverse events Related to study |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incidental Finding | Investigations | Serious | Non-systematic Assessment | Any incidental findings that noted during study related ultrasound and required further clinical workup |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John P Fischer | University of Pennsylvania | 2156627300 | john.fischer2@uphs.upenn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2015 | Feb 20, 2019 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Incidental Findings and Ultrasound Safety |
Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging |
| 1 year |
Fourteen volunteers without ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) |
| BG002 | Active Health Volunteers | Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 9L4 No Pressure External Oblique Shear Wave Velocity | For this measurement, a 9L4 probe is applied to the subjects abdomen without any pressure from the examiner, while the subject is holding end expiration. The shear wave velocity (m/s) is measured along the subject's external oblique muscle. | Mean | Full Range | meters per second |
|
Fourteen volunteers without ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) |
| OG002 | Active Health Volunteers | Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) |
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | meters per second | through study completion, an up to 26 weeks postoperative |
|
|
|
| Secondary | Incidental Findings and Ultrasound Safety | Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging | Posted | Number | Participants | 1 year |
|
|
|
| 0 |
| 21 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Healthy Volunteers | Fourteen volunteers without ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) No adverse events Related to study | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Active Health Volunteers | Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) No adverse events Related to study | 0 | 10 | 0 | 10 | 0 | 10 |
|
Not provided
Not provided
Not provided