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Enrolling by Invitation

NCT Number: NCT06306976

Shear-Wave Elastography

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prisma Health

Greenville, South Carolina, 29615, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients >18 y/o.
  • Midline ventral / incisional hernia.
  • Plan for open retromuscular incisional hernia repair.

Exclusion criteria

  • 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.

Treatment and study plan

Elective Midline Laparotomy

Procedure

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: Ultrasound

Procedure

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.

Tensiometry

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Official study title

Assessment of the Ability to Predict Fascial Closure Using Shear-wave Elastography in Patients With Midline Incisional Hernias.

Acronym: ELASTOGRAPHY

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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