Ultrasound Imaging for Incisional Hernia
(ELASTOGRAPHY Trial)

Recruiting in Palo Alto (17 mi)

Overseen byWes Love, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Prisma Health-Upstate

No Placebo Group

Trial Summary

What is the purpose of this trial?Prospective cohort study of patients with midline ventral incisional hernia with a range of hernia morphology who plan to undergo open retromuscular VHR. Study groups: Study groups are selected across a range of morphology and based on factors known or suspected to affect the ability to achieve fascial closure. Control groups: The study plans to enlist 5 volunteers with no incisional hernia or prior laparotomy to establish internal baseline SWE values and interrater reliability. The study will also plan to recruit 5 patients undergoing primary laparotomy in order to correlate SWE findings with closure tension.

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 years old.

I have a hernia along the middle of my abdomen or at a previous cut site.

I am scheduled for an open hernia repair surgery in the retromuscular area.

Exclusion Criteria

I have had surgery to repair a hernia in my abdomen using mesh.

My case is not infected or contaminated.

I have had surgery with an incision on my side.

+2 more

Participant Groups

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.

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