Ultrasound Assessment of Ventral Hernia Defects

Ventral Incisional Hernia Clinical Trial

Official title:

Ultrasound Assessment of Ventral Hernia Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03043079
• Other study ID #: 823896
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: September 15, 2017

Study information

• Verified date: March 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• male or female between 20-70 years of age

• healthy volunteer or seeking elective ventral hernia repair

Exclusion Criteria:

• pregnant women

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Ventral Incisional Hernia

Intervention

Diagnostic Test:
• Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity
Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incidental Findings and Ultrasound Safety	Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging	1 year