Ultrasound Assessment of Ventral Hernia Defects

University of Pennsylvania

Status: Completed

Conditions: Ventral Incisional Hernia

Treatments: Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity

Study type: Interventional

Funder types: Other

Identifiers

NCT03043079

823896

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• pregnant women

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Ventral Hernia

Experimental group

Description:

Twenty-five patients diagnosed with ventral hernia

Treatment:

Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity

Healthy Volunteers

Other group

Description:

Twenty-five volunteers without ventral hernia

Treatment:

Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity

Active Health Volunteers

Other group

Description:

Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity

Treatment:

Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity