protocolSection identificationModule nctId: NCT06306976, orgStudyIdInfo id: 2066031, briefTitle: Shear-Wave Elastography, acronym: ELASTOGRAPHY, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Prisma Health-Upstate, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Ventral Incisional Hernia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: 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., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Elective Midline Laparotomy, interventions name: Imaging: Ultrasound, interventions name: Tensiometry, outcomesModule primaryOutcomes measure: Determine Elasticity of Abdominal Wall Muscles (Specific Aim 1), primaryOutcomes measure: Correlate Elastography measurements with MFR (Specific Aim 2), primaryOutcomes measure: Correlate SWE Assessment to Tensiometer (Specific Aim 3), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prisma Health, city: Greenville, state: South Carolina, zip: 29615, country: United States, geoPoint lat: 34.85262, lon: -82.39401, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-06-01, uploadDate: 2024-03-11T16:32, filename: Prot_000.pdf, size: 301771, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2023-07-12, uploadDate: 2024-03-11T16:33, filename: SAP_001.pdf, size: 170975, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-07-12, uploadDate: 2024-03-11T16:33, filename: ICF_002.pdf, size: 179351, hasResults: False