Shear-Wave Elastography

NAEnrolling by invitationINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

April 18, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

August 31, 2026

Conditions
Ventral Incisional Hernia
Interventions
PROCEDURE

Elective Midline Laparotomy

"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."

PROCEDURE

Imaging: Ultrasound

"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."

OTHER

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."

Trial Locations (1)

29615

Prisma Health, Greenville

All Listed Sponsors
lead

Prisma Health-Upstate

OTHER