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

70 Participants Needed

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.

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 data supports the effectiveness of the treatment Shear-Wave Elastography for incisional hernia?

Shear-Wave Elastography (SWE) is a promising non-invasive method that can help assess the stiffness of tissues, which is useful in planning surgeries for hernia repair. It has been shown to reliably measure tissue stiffness, which can aid in evaluating the integrity of hernia repairs and potentially improve surgical outcomes. ^{1 2 3 4 5}

Is shear wave elastography safe for use in humans?

Shear wave elastography (SWE) is a type of ultrasound used to measure tissue stiffness and has been studied in various conditions, including muscle tissues and breast lesions. It is generally considered safe as it is non-invasive and uses sound waves, similar to regular ultrasound, which is widely used in medical imaging. ^{1 6 7 8 9}

How does ultrasound imaging differ from other treatments for incisional hernia?

Ultrasound imaging, specifically using shear wave elastography (SWE), is unique because it allows for non-invasive assessment of tissue stiffness and the integrity of hernia repairs, which is not possible with other imaging methods like CT scans. This approach can help in planning surgeries by providing detailed information about the mechanical properties of the abdominal wall and the implanted mesh. ^{1 3 4 5 10}

Research Team

Wes Love, MD

Principal Investigator

Prisma Health

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.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Characterization of ventral incisional hernia and repair using shear wave elastography. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Muscle elasticity is different in individuals with diastasis recti abdominis than healthy volunteers. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Shear wave elastography biases in abdominal wall layers characterization. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The effect of breathing on the in vivo mechanical characterization of linea alba by ultrasound shearwave elastography. [2023]

5. China pubmed.ncbi.nlm.nih.gov

Effect of acquisition depth and precompression from probe and couplant on shear wave elastography in soft tissue: an in vitro and in vivo study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Inter-operator and inter-device reproducibility of shear wave elastography in healthy muscle tissues. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Reliability Indicators for 2-Dimensional Shear Wave Elastography. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Prognostic values of shear wave elastography in adolescent boys with varicocele. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Improved Breast 2D SWE Algorithm to Eliminate False-Negative Cases. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Quantitative Analysis of Abdominal Muscles Using Elastography in Female Patients With Incisional Hernia. [2022]