Ultrasound Assessment of Ventral Hernia Defects

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.

Study Overview

• Status: Completed
• Conditions: Ventral Incisional Hernia
• Intervention / Treatment: Diagnostic test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • University of Pennsylvania Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• male or female between 20-70 years of age
• healthy volunteer or seeking elective ventral hernia repair

Exclusion Criteria:

• pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ventral Hernia; Twenty-five patients diagnosed with ventral hernia	Diagnostic test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity; Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)
Other: Healthy Volunteers; Twenty-five volunteers without ventral hernia	Diagnostic test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity; Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)
Other: Active Health Volunteers; Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity	Diagnostic test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity; Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Incidental Findings and Ultrasound Safety	Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging	1 year

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): September 15, 2017
• Study Completion (Actual): September 15, 2017

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Incisional Hernia
• Other Study ID Numbers: 823896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No