Ventral Incisional HerniaELASTOGRAPHYNCT06306976
Shear-Wave Elastography
A study testing Elective Midline Laparotomy, Imaging: Ultrasound and Tensiometry in people with Ventral Incisional Hernia, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventral Incisional Hernia
- What is being tested?
- Elective Midline Laparotomy, Imaging: Ultrasound and Tensiometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients >18 y/o.
- Midline ventral / incisional hernia.
- Plan for open retromuscular incisional hernia repair.
Who cannot join
- Prior VHR with mesh.
- Isolated subxiphoid (European Hernia Society (EHS) classification M1) or suprapubic hernias (EHS classification M5)
- History of flank incisions. M1 (midline position 1) is defined as the xiphoid process down to a point 3cm below the xiphoid. M5 (midline position 5) is defined as the pubis to a point 3cm above the pubis.
- Infected / contaminated cases.
- Plan for robotic, laparoscopic, or open onlay repair, or plan for primary (non-mesh) repair.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of the Ability to Predict Fascial Closure Using Shear-wave Elastography in Patients With Midline Incisional Hernias.
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.
Read the detailed description
Shear wave elastography can be used to predict abdominal wall compliance pre-operatively and can therefore be used as a tool to improve surgical outcomes.
Specific Aim 1:
Determine the elasticity of abdominal wall muscles (rectus abdominis, external oblique, internal oblique, and transversus abdominis) through shear wave elastography in patients with midline incisional hernias of varying complexity and morphology.
Specific Aim 2:
Correlate shear wave elastography measurements of the abdominal wall with the extent of MFR required to achieve fascial closure.
Specific Aim 3:
Correlate SWE-determined elasticity of abdominal wall to intraoperative assessment of tension required to achieve fascial closure.
Imaging:
Ultrasound procedure will involve the following steps:
- For control group 1 and group 2 patients, Images will be taken at two points along the bilateral RA; at the level of the umbilicus and midway between the umbilicus and xiphoid process. Bilateral external oblique (EO), internal oblique (IO), and transversus abdominis (TA) images will be performed at the level of the anterior axillary line midway between the costal margin and iliac crest.
- For study patients, a single point of the bilateral RA will be selected at the longitudinal mid-point of the hernia defect. Bilateral EO, IO, and TA images will be performed at the level of the anterior axillary line midway between the costal margin and iliac crest.
- Gray-scale imaging will first determine thickness and texture of each muscle layer. Texture analysis includes use of overlying subcutaneous fat as the internal control value.
- SWE will be performed at each location with three successive maneuvers:
- With minimal external pressure applied by the ultrasound probe.
- Manual compression applied with the ultrasound probe (maximum pressure allowable without causing patient discomfort).
- During Valsalva.
Hernia repair:
All study patients will have an open retromuscular repair with/without additional lateral MFR (TAR or EOR at the discretion of the operating surgeon). All repairs beginning with retrorectus dissection to the level of the linea semilunaris. When needed, additional MFR progresses as follows:
- For posterior myofascial release (TAR):
- Incision of the posterior lamella of the internal oblique (PLIO) just medial the intercostal neurovascular bundles and linea semilunaris
- Division of the transversus abdominis muscle / aponeurosisis
- Lateral dissection to progressively separate the peritoneum from the transversus abdominis.
- For anterior release (EOR):
- Subcutaneous flaps developed to the anterior or midaxillary line bilaterally.
- Division of the external oblique fascial and muscle 1cm or greater from the lateral border of the rectus sheath / linea semilunaris.
- Lateral dissection to progressively separate the external and internal oblique muscles.
All patients will have permanent mesh reinforcement of the abdominal wall (large-pore, midweight polypropylene). Fascia will be closed over the mesh with 0 or 2-0 polydioxanone slowly absorbable suture using a small-bite technique and a 4:1 suture length:wound length ratio.
Control group 1 patients will have no incisional hernia or prior laparotomy.
Control group 2 patients will have no hernia and will be undergoing elective midline laparotomy.
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. The tensiometer is attached to a clamp attached to the fascia at the midpoint of the hernia defect. Tension required for medialization to the midline will be performed after adhesiolysis (baseline), retrorectus dissetion, incision of the PLIO (if performed), and after completion of TAR or EOR (if performed).
Control group 2 patients will be undergoing first time laparotomy and will have tensiometry performed. As control group 1 is not having surgery, no tensiometry will be done.
- Conditions
- Ventral Incisional Hernia
- Being tested
- Elective Midline Laparotomy, Imaging: Ultrasound, Tensiometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective Midline LaparotomyProcedure or surgery
Patients with midline ventral incisional hernia with a range of hernia morphology who plan to undergo open retromuscular VHR.
Hernia repair:
All study patients will have an open retromuscular repair with/without additional lateral MFR (TAR or EOR at the discretion of the operating surgeon). All repairs beginning with retrorectus dissection to the level of the linea semilunaris.
All patients will have permanent mesh reinforcement of the abdominal wall (large-pore, midweight polypropylene). Fascia will be closed over the mesh with 0 or 2-0 polydioxanone slowly absorbable suture using a small-bite technique and a 4:1 suture length:wound length ratio.
Imaging: UltrasoundProcedure or surgery
Ultrasound procedure will involve the following steps:
- For control group 1 and group 2 patients, Images will be taken at two points along the bilateral RA; at the level of the umbilicus and midway between the umbilicus and xiphoid process. Bilateral external oblique (EO), internal oblique (IO), and transversus abdominis (TA) images will be performed at the level of the anterior axillary line midway between the costal margin and iliac crest.
TensiometryOther
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. The tensiometer is attached to a clamp attached to the fascia at the midpoint of the hernia defect. Tension required for medialization to the midline will be performed after adhesiolysis (baseline), retrorectus dissetion, incision of the PLIO (if performed), and after completion of TAR or EOR (if performed).
Control group 2 patients will be undergoing first time laparotomy and will have tensiometry performed.
| Study group | Role | What they receive |
|---|---|---|
| Control Group 1 | Other | 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 Receives: Procedure: Imaging: Ultrasound |
| Control Group 2 | Other | 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. Receives: Procedure: Elective Midline Laparotomy; Procedure: Imaging: Ultrasound; Other: Tensiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Elasticity of Abdominal Wall Muscles (Specific Aim 1)
Determine the elasticity of abdominal wall muscles (rectus abdominis, external oblique, internal oblique, and transversus abdominis) through shear wave elastography in patients with midline incisional hernias of varying complexity and morphology using Ultrasound measurements.
Measured: Study participation ends after surgery
Correlate Elastography measurements with MFR (Specific Aim 2)
Correlate shear wave elastography measurements of the abdominal wall with the extent of MFR required to achieve fascial closure using Ultrasound measurements.
Measured: Study participation ends after surgery
Correlate SWE Assessment to Tensiometer (Specific Aim 3)
Correlate SWE-determined elasticity of abdominal wall to intraoperative assessment of tension required to achieve fascial closure using Tensiometry.
Measured: Study participation ends after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start18 Apr 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Specific Aim 1: Determine the elasticity of abdominal wall muscles (rectus abdominis, external oblique, internal oblique, and transversus abdominis) through shear wave elastography in patients with midline incisional hernias of varying complexity and morphology. Specific Aim 2: Correlate shear wave elastography measurements of the abdominal wall with the extent of MFR required to achieve fascial closure. Specific Aim 3: Correlate SWE-determined elasticity of abdominal wall to intraoperative assessment of tension required to achieve fascial closure.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wes Love, MD, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306976
- Sponsor's protocol ID
- 2066031
- Acronym
- ELASTOGRAPHY
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Ability to Predict Fascial Closure Using Shear-wave Elastography in Patients With Midline Incisional Hernias.
- ClinicalTrials.gov ID
- NCT06306976
- Acronym / sponsor ID
- ELASTOGRAPHY / 2066031
- Conditions
- Ventral Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Shear wave elastography can be used to predict abdominal wall compliance pre-operatively and can therefore be used as a tool to improve surgical outcomes.
Specific Aim 1:
Determine the elasticity of abdominal wall muscles (rectus abdominis, external oblique, internal oblique, and transversus abdominis) through shear wave elastography in patients with midline incisional hernias of varying complexity and morphology.
Specific Aim 2:
Correlate shear wave elastography measurements of the abdominal wall with the extent of MFR required to achieve fascial closure.
Specific Aim 3:
Correlate SWE-determined elasticity of abdominal wall to intraoperative assessment of tension required to achieve fascial closure.
Imaging:
Ultrasound procedure will involve the following steps:
- For control group 1 and group 2 patients, Images will be taken at two points along the bilateral RA; at the level of the umbilicus and midway between the umbilicus and xiphoid process. Bilateral external oblique (EO), internal oblique (IO), and transversus abdominis (TA) images will be performed at the level of the anterior axillary line midway between the costal margin and iliac crest.
- For study patients, a single point of the bilateral RA will be selected at the longitudinal mid-point of the hernia defect. Bilateral EO, IO, and TA images will be performed at the level of the anterior axillary line midway between the costal margin and iliac crest.
- Gray-scale imaging will first determine thickness and texture of each muscle layer. Texture analysis includes use of overlying subcutaneous fat as the internal control value.
- SWE will be performed at each location with three successive maneuvers:
- With minimal external pressure applied by the ultrasound probe.
- Manual compression applied with the ultrasound probe (maximum pressure allowable without causing patient discomfort).
- During Valsalva.
Hernia repair:
All study patients will have an open retromuscular repair with/without additional lateral MFR (TAR or EOR at the discretion of the operating surgeon). All repairs beginning with retrorectus dissection to the level of the linea semilunaris. When needed, additional MFR progresses as follows:
- For posterior myofascial release (TAR):
- Incision of the posterior lamella of the internal oblique (PLIO) just medial the intercostal neurovascular bundles and linea semilunaris
- Division of the transversus abdominis muscle / aponeurosisis
- Lateral dissection to progressively separate the peritoneum from the transversus abdominis.
- For anterior release (EOR):
- Subcutaneous flaps developed to the anterior or midaxillary line bilaterally.
- Division of the external oblique fascial and muscle 1cm or greater from the lateral border of the rectus sheath / linea semilunaris.
- Lateral dissection to progressively separate the external and internal oblique muscles.
All patients will have permanent mesh reinforcement of the abdominal wall (large-pore, midweight polypropylene). Fascia will be closed over the mesh with 0 or 2-0 polydioxanone slowly absorbable suture using a small-bite technique and a 4:1 suture length:wound length ratio.
Control group 1 patients will have no incisional hernia or prior laparotomy.
Control group 2 patients will have no hernia and will be undergoing elective midline laparotomy.
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. The tensiometer is attached to a clamp attached to the fascia at the midpoint of the hernia defect. Tension required for medialization to the midline will be performed after adhesiolysis (baseline), retrorectus dissetion, incision of the PLIO (if performed), and after completion of TAR or EOR (if performed).
Control group 2 patients will be undergoing first time laparotomy and will have tensiometry performed. As control group 1 is not having surgery, no tensiometry will be done.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Specific Aim 1: Determine the elasticity of abdominal wall muscles (rectus abdominis, external oblique, internal oblique, and transversus abdominis) through shear wave elastography in patients with midline incisional hernias of varying complexity and morphology. Specific Aim 2: Correlate shear wave elastography measurements of the abdominal wall with the extent of MFR required to achieve fascial closure. Specific Aim 3: Correlate SWE-determined elasticity of abdominal wall to intraoperative assessment of tension required to achieve fascial closure.
| Arm | Type | Receives |
|---|---|---|
| Control Group 1 | Other | Procedure: Imaging: UltrasoundControl 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 |
| Control Group 2 | Other | Procedure: Elective Midline Laparotomy, Procedure: Imaging: Ultrasound, Other: TensiometryControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients >18 y/o.
- Midline ventral / incisional hernia.
- Plan for open retromuscular incisional hernia repair.
Key exclusion criteria (5 listed)
- Prior VHR with mesh.
- Isolated subxiphoid (European Hernia Society (EHS) classification M1) or suprapubic hernias (EHS classification M5)
- History of flank incisions. M1 (midline position 1) is defined as the xiphoid process down to a point 3cm below the xiphoid. M5 (midline position 5) is defined as the pubis to a point 3cm above the pubis.
- Infected / contaminated cases.
- Plan for robotic, laparoscopic, or open onlay repair, or plan for primary (non-mesh) repair.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective Midline LaparotomyPatients with midline ventral incisional hernia with a range of hernia morphology who plan to undergo open retromuscular VHR. Hernia repair: All study patients will have an open retromuscular repair with/without additional lateral MFR (TAR or EOR at the discretion of the operating surgeon). All repairs beginning with retrorectus dissection to the level of the linea semilunaris. All patients will have permanent mesh reinforcement of the abdominal wall (large-pore, midweight polypropylene). Fascia will be closed over the mesh with 0 or 2-0 polydioxanone slowly absorbable suture using a small-bite technique and a 4:1 suture length:wound length ratio. | Procedure or surgery | Control Group 2 |
| Imaging: UltrasoundUltrasound procedure will involve the following steps: 1. For control group 1 and group 2 patients, Images will be taken at two points along the bilateral RA; at the level of the umbilicus and midway between the umbilicus and xiphoid process. Bilateral external oblique (EO), internal oblique (IO), and transversus abdominis (TA) images will be performed at the level of the anterior axillary line midway between the costal margin and iliac crest. | Procedure or surgery | Control Group 1, Control Group 2 |
| TensiometryFor all study patients, an analog spring-tensiometer will be used to assess intraoperative tension required to bring the fascia to the midline for closure. The tensiometer is attached to a clamp attached to the fascia at the midpoint of the hernia defect. Tension required for medialization to the midline will be performed after adhesiolysis (baseline), retrorectus dissetion, incision of the PLIO (if performed), and after completion of TAR or EOR (if performed). Control group 2 patients will be undergoing first time laparotomy and will have tensiometry performed. | Other | Control Group 2 |
Primary outcome
Determine Elasticity of Abdominal Wall Muscles (Specific Aim 1)
Time frame: Study participation ends after surgery
Determine the elasticity of abdominal wall muscles (rectus abdominis, external oblique, internal oblique, and transversus abdominis) through shear wave elastography in patients with midline incisional hernias of varying complexity and morphology using Ultrasound measurements.
Correlate Elastography measurements with MFR (Specific Aim 2)
Time frame: Study participation ends after surgery
Correlate shear wave elastography measurements of the abdominal wall with the extent of MFR required to achieve fascial closure using Ultrasound measurements.
Correlate SWE Assessment to Tensiometer (Specific Aim 3)
Time frame: Study participation ends after surgery
Correlate SWE-determined elasticity of abdominal wall to intraoperative assessment of tension required to achieve fascial closure using Tensiometry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wes Love, MD principal investigator
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elective Midline Laparotomy, Imaging: Ultrasound and Tensiometry in people with Ventral Incisional Hernia, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Elasticity of Abdominal Wall Muscles (Specific Aim 1) (time frame: Study participation ends after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.