Ultrasound Assessment of Ventral Hernia Defects
Primary Purpose
Ventral Incisional Hernia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventral Incisional Hernia
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
Sites / Locations
- University of Pennsylvania Health System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
Other
Arm Label
Ventral Hernia
Healthy Volunteers
Active Health Volunteers
Arm Description
Twenty-five patients diagnosed with ventral hernia
Twenty-five volunteers without ventral hernia
Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Incidental Findings and Ultrasound Safety
Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging
Full Information
NCT ID
NCT03043079
First Posted
January 24, 2017
Last Updated
March 11, 2020
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03043079
Brief Title
Ultrasound Assessment of Ventral Hernia Defects
Official Title
Ultrasound Assessment of Ventral Hernia Defects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
September 15, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Incisional Hernia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ventral Hernia
Arm Type
Experimental
Arm Description
Twenty-five patients diagnosed with ventral hernia
Arm Title
Healthy Volunteers
Arm Type
Other
Arm Description
Twenty-five volunteers without ventral hernia
Arm Title
Active Health Volunteers
Arm Type
Other
Arm Description
Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity
Intervention Description
Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)
Primary Outcome Measure Information:
Title
Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall
Description
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
Secondary Outcome Measure Information:
Title
Difference in Shear Wave Velocity Measurement in the Abdominal Wall Pre and Post Hernia Repair
Description
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
Title
Incidental Findings and Ultrasound Safety
Description
Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Ultrasound Assessment of Ventral Hernia Defects
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