Ultrasound Assessment of Ventral Hernia Defects

Not Applicable

Completed

• Conditions: Ventral Incisional Hernia
• Interventions: Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity

• Registration Number: NCT03043079
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Primary Completion: 2017-09-15
• Study Completion: 2017-09-15
• Results First Submitted: 2018-09-07
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-11
• Last Update Submitted: 2020-03-11
• Results First Posted: 2020-03-24
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

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Exclusion Criteria

• pregnant women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity	Twenty-five volunteers without ventral hernia
Active Health Volunteers	Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity	Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity
Ventral Hernia	Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity	Twenty-five patients diagnosed with ventral hernia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States