Ultrasound Imaging for Incisional Hernia

(ELASTOGRAPHY Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Prisma Health-Upstate

Disqualifiers: Prior VHR with mesh, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on using ultrasound imaging to study incisional hernias, which are bulges at the site of a previous surgical incision. The research aims to understand how different hernia shapes affect the success of surgical repair. Participants will undergo Shear-Wave Elastography, a type of ultrasound, to measure tissue properties. The trial seeks individuals with a midline ventral incisional hernia who plan to have it surgically repaired using a specific method. Those with previous hernia repairs involving mesh or certain types of hernias are not eligible. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially improve future hernia repair outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this ultrasound imaging technique is safe for patients with incisional hernia?

Research has shown that Shear-Wave Elastography (SWE) is a promising method for studying the properties of abdominal muscles in individuals with hernias. Studies have found that this imaging technique effectively identifies differences in muscle stiffness between those with incisional hernias and healthy individuals. Importantly, no major safety concerns or negative effects have been reported from using SWE.

While data on SWE highlights its effectiveness in measuring muscle properties, the absence of reported side effects suggests it is well-tolerated in these studies. Since this trial is in the "Not Applicable" phase, SWE is likely considered safe enough for use, as it is not a new drug or invasive procedure. Overall, SWE appears to be a safe and useful tool for assessing hernias. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using shear-wave elastography for incisional hernia detection because it offers a non-invasive and precise way to assess tissue stiffness. Unlike traditional methods that might rely on manual examination or basic imaging techniques, shear-wave elastography provides detailed, real-time insights into the mechanical properties of tissues. This helps in better diagnosing and planning for hernia repairs, potentially leading to more effective treatments and faster recovery times.

What evidence suggests that shear-wave elastography is effective for imaging incisional hernia?

Research has shown that Shear-Wave Elastography (SWE) effectively detects ventral incisional hernias. Studies demonstrate that SWE measures abdominal muscle stiffness, aiding in hernia detection and monitoring repair progress. For example, one study found that shear wave speed, indicating tissue stiffness, was higher in patients with hernias than in those without. This suggests that SWE can distinguish between healthy tissue and hernia-affected areas. Overall, SWE appears promising for enhancing hernia detection and treatment. Participants in this trial will be divided into two control groups to further evaluate SWE's effectiveness in different patient scenarios. ^{2 3 5 6 7}

Who Is on the Research Team?

Wes Love, MD

Principal Investigator

Prisma Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Ultrasound imaging to determine elasticity of abdominal wall muscles and establish baseline SWE values

1-2 weeks

1 visit (in-person)

Surgery

Open retromuscular hernia repair with potential additional lateral myofascial release and tensiometry

1 day

1 visit (in-person)

Follow-up

Participants are monitored for surgical outcomes and recovery post-surgery

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Shear-Wave Elastography

Trial Overview 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.

How Is the Trial Designed?

Group I: Control Group 2 Experimental Treatment 3 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 1 Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Prisma Health-Upstate

Lead Sponsor

Trials

91

Recruited

47,500+

Published Research Related to This Trial

The updated 2D shear wave elastography (SWE) algorithm significantly improves the sensitivity for detecting breast lesions, increasing from 45% to 100% compared to the standard algorithm, while still maintaining a high negative predictive value of 100%.

This new algorithm also helps to reduce false-negative results associated with 'soft' cancer artifacts, allowing for more accurate characterization of breast lesions and the potential to downgrade all BI-RADS 4 lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Breast 2D SWE Algorithm to Eliminate False-Negative Cases. Barr, RG., Engel, A., Kim, S., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28457335/

Characterization of ventral incisional hernia and repair ... In this study, we demonstrate the feasibility of using US SWE to detect ventral hernias and evaluate mesh repair in vivo. Our results indicate that the ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480416305200

Characterization of ventral incisional hernia and repair ... In this study, we demonstrate the feasibility of using US SWE to detect ventral hernias and evaluate mesh repair in vivo. Our results indicate that the presence ...

3. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.831184/full

Quantitative Analysis of Abdominal Muscles Using ... This study aimed to assess the thickness and shear wave speed (SWS) of the anterolateral abdominal wall muscles in female patients with incisional hernias of ...

4. umbjournal.org umbjournal.org/article/S0301-5629(20)30143-5/abstract

Use of Shear Wave Elastography to Quantify Abdominal ... The SWS of RA, EO, IO and TrA was significantly higher in the incisional hernia patient group than in the healthy controls (p < 0.05).

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301562920301435

Use of Shear Wave Elastography to Quantify Abdominal ... Results. Elastography was consecutively performed for 28 female patients with incisional hernia and 14 healthy controls. No statistical differences were noted ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9039235/

Quantitative Analysis of Abdominal Muscles Using ... This study aimed to assess the thickness and shear wave speed (SWS) of the anterolateral abdominal wall muscles in female patients with incisional hernias of ...

7. researchgate.net researchgate.net/publication/341292730_Use_of_Shear_Wave_Elastography_to_Quantify_Abdominal_Wall_Muscular_Properties_in_Patients_With_Incisional_Hernia

Use of Shear Wave Elastography to Quantify Abdominal ... The SWS of RA, EO, IO and TrA was significantly higher in the incisional hernia patient group than in the healthy controls (p < 0.05). Significant differences ...