N/A
N=45
Ultrasound Assessment of Ventral Hernia Defects
Ventral Incisional Hernia
Bottom Line
View on ClinicalTrials.gov: NCT03043079 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall — 1.89; 1.92; 1.89 meters per second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (Diagnostic_test)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall |
1.89; 1.92; 1.89 | — |
| SECONDARY Difference in Shear Wave Velocity Measurement in the Abdominal Wall Pre and Post Hernia Repair |
1.726 | — |
| SECONDARY Incidental Findings and Ultrasound Safety |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- male or female between 20-70 years of age
- healthy volunteer or seeking elective ventral hernia repair
Exclusion Criteria
- pregnant women
Data sourced from ClinicalTrials.gov (NCT03043079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.