protocolSection identificationModule nctId: NCT06364306, orgStudyIdInfo id: 12032024, briefTitle: oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias, acronym: PRIOR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2031-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, collaborators name: St. Clara Hospital, Basel, Switzerland, collaborators name: Klinikum Kempten, Kempten, Germany, descriptionModule briefSummary: This study investigates on the effect of two different operative techniques to treat large abdominal wall defects.The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR).The main questions it aims to answer are:length of stay after the operation rate of complications rate of recurrence and reoperations quality of life.Participants will:Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes., conditionsModule conditions: Ventral Hernia, conditions: Incisional Hernia, conditions: Abdominal Wall Defect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Patients are blinded to their treatment allocation until hospital discharge criteria according to the primary endpoint are fulfilled. After discharge, blinding is difficult to be ensured because there is no control, if dressing have been removed or modified. To ensure patient blinding during hospital stay, patients from both treatment arms will receive identical dressings as if an open and minimal-invasive access had been performed. In case the dressing must be changed during the hospital stay, this will be performed while the patient is blinded using a cover.In case for any reason the patient has been unblinded to his treatment allocation (accidental or intentional dressing removal, bed-side wound opening, other) all outcome data are assessed regardless and unblinding is documented and reported in the final report., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Robotically-assisted ventral hernia repair (RVHR), interventions name: Open ventral hernia repair (OVHR), outcomesModule primaryOutcomes measure: Primary outcome: length of stay, secondaryOutcomes measure: Comprehensive complication index (CCI), secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: pain after surgery, secondaryOutcomes measure: Functional recovery, secondaryOutcomes measure: Quality of life using SF-12 form, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False