Ventral Incisional Hernia
Conditions
Brief 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 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.
Interventions
DIAGNOSTIC_TESTUltrasound Acoustic Radiation Forced Impulse Shear Wave Velocity
Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)
Sponsors
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* male or female between 20-70 years of age * healthy volunteer or seeking elective ventral hernia repair
Exclusion criteria
* pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Shear Wave Velocity Measurement in the Abdominal Wall Pre and Post Hernia Repair | through study completion, an up to 26 weeks postoperative | 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 |
| Incidental Findings and Ultrasound Safety | 1 year | Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 21 |
| 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) | 14 |
| 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) | 10 |
| Total | 45 |
Baseline characteristics
| Characteristic | Ventral Hernia | Healthy Volunteers | Active Health Volunteers | Total |
|---|---|---|---|---|
| 9L4 No Pressure External Oblique Shear Wave Velocity | 1.94 meters per second | 1.9 meters per second | 1.97 meters per second | 1.9 meters per second |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 0 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 12 Participants | 10 Participants | 38 Participants |
| Age, Continuous | 58.3 years STANDARD_DEVIATION 7.9 | 60.5 years STANDARD_DEVIATION 5.4 | 27.0 years STANDARD_DEVIATION 3.17 | 48.6 years STANDARD_DEVIATION 14.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 9 Participants | 7 Participants | 32 Participants |
| Region of Enrollment United States | 21 participants | 14 participants | 10 participants | 45 participants |
| Sex: Female, Male Female | 11 Participants | 8 Participants | 4 Participants | 23 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 6 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 14 | 0 / 10 |
| other Total, other adverse events | 0 / 24 | 0 / 14 | 0 / 10 |
| serious Total, serious adverse events | 0 / 24 | 0 / 14 | 0 / 10 |
Outcome results
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
Time frame: study intiation ultrasound scan lasting up to 45 minutes
Population: 21 ventral hernia age and BMI matched to 14 health volunteers with 10 active volunteers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ventral Hernia | Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall | 1.89 meters per second | Standard Deviation 0.31 |
| Healthy Volunteers | Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall | 1.92 meters per second | Standard Deviation 0.46 |
| Active Health Volunteers | Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall | 1.89 meters per second | Standard Deviation 0.13 |
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
Time frame: through study completion, an up to 26 weeks postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ventral Hernia | Difference in Shear Wave Velocity Measurement in the Abdominal Wall Pre and Post Hernia Repair | 1.726 meters per second | Standard Deviation 0.36 |
Secondary
Incidental Findings and Ultrasound Safety
Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ventral Hernia | Incidental Findings and Ultrasound Safety | 0 Participants |