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Ultrasound Imaging for Incisional Hernia (ELASTOGRAPHY Trial)

N/A

Waitlist Available

Led By Wes Love, MD

Research Sponsored by Prisma Health-Upstate

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study participation ends after surgery

Awards & highlights

No Placebo-Only Group

Summary

"This trial will study patients with midline ventral incisional hernia undergoing open retromuscular VHR. They will be divided into study groups based on hernia morphology and factors affecting fasc

Who is the study for?

This trial is for patients with midline ventral incisional hernias who are scheduled for open retromuscular ventral hernia repair (VHR). It includes a variety of hernia shapes and sizes. Healthy volunteers without hernias and those having primary laparotomy will serve as controls to establish baseline measurements.

What is being tested?

The study is testing the use of Shear-Wave Elastography (SWE), a type of ultrasound imaging, to measure tissue stiffness in patients undergoing surgery for incisional hernias. The goal is to understand how different factors affect the ability to close the fascial defect during VHR.

What are the potential side effects?

Since this trial involves non-invasive imaging techniques like ultrasound, side effects are minimal. However, there may be some discomfort or minor risks associated with tensiometry and elective midline laparotomy used in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study participation ends after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study participation ends after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and study participation ends after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Correlate Elastography measurements with MFR (Specific Aim 2)

Correlate SWE Assessment to Tensiometer (Specific Aim 3)

Determine Elasticity of Abdominal Wall Muscles (Specific Aim 1)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Control Group 2Experimental Treatment3 Interventions

Control group 2 patients will have no hernia and will be undergoing elective midline laparotomy. Imaging: Ultrasound procedure will involve the following steps: 1. For control group 1 and group 2 patients, Images will be taken at two points . Hernia repair: All study patients will have an open retromuscular repair with/without additional lateral Tensiometry For all study patients, an analog spring-tensiometer will be used to assess intraoperative tension required to bring the fascia to the midline for closure.

Group II: Control Group 1Experimental Treatment1 Intervention

Control group 1 patients will have no incisional hernia or prior laparotomy. Imaging: Ultrasound procedure will involve the following steps: 1. For control group 1 and group 2 patients, Images will be taken at two points

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