An interventional study of Elective Midline Laparotomy and Imaging: Ultrasound in Ventral Incisional Hernia, sponsored by Prisma Health-Upstate. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Prisma Health-Upstate · Not applicable, Interventional, and Other
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.
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:
SWE will be performed at each location with three successive maneuvers:
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):
For anterior release (EOR):
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.
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
This study's planned enrollment of 90 is below the median of 110 across 130 interventional studies indexed under Incisional Hernia.
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Exclusion Criteria:
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
Procedure: Imaging: Ultrasound
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.
Procedure: Elective Midline Laparotomy · Procedure: Imaging: Ultrasound · Other: Tensiometry
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.
Ultrasound 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Study participation ends after surgery
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Prisma Health-Upstate