[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544086":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":34,"locations":11,"responsibleParty":40,"collaborators":42,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":11,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":11,"overallStatus":69,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":11},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Robotically-assisted ventral hernia repair (RVHR)","EXPERIMENTAL",null,[13],"Procedure: Robotically-assisted ventral hernia repair (RVHR)",{"label":15,"type":16,"description":11,"interventionNames":17},"Open ventral hernia repair (OVHR)","ACTIVE_COMPARATOR",[18],"Procedure: Open ventral hernia repair (OVHR)",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"PROCEDURE","3 8mm robotic trocars are placed intraabdominally and the DaVinci Xi-robotic system is docked. Adhesiolysis from any adherent structures to the abdominal wall is performed. Incision of the lateral verge of the retromuscular space and retromuscular dissection. Superior and inferior cross-over to the contralateral retromuscular space and dissection of the hernia sac.\n\nUnilateral or bilateral transversus abdominis release (TAR) is performed, if necessary. Running suture with absorbable barbed suture of the posterior rectus sheath and peritoneum, as appropriate. Synthetic retromuscular mesh placement with a mesh-size as large as the prepared surface allows. Closure of the anterior rectus sheath with absorbable barbed running suture. Port extraction, skin closure. Dressing from xyphoid to pubis and 6 lateral dressings for blinding purposes.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Median laparotomy with a minimal length of the previous scar (in case of incisional hernia) and adhesiolysis is performed, where necessary, to liberate the abdominal wall and the ventral hernia from adhesions. Bilateral dissection of the posterior rectus sheath under visualisation and sparing of the epigastric vessels and neurovascular bundles. Closure of the posterior rectus sheath with a slowly-absorbable running suture. Indication for a uni- or bilateral TAR identical to the intervention group. Retromuscular synthetic mesh placement with a mesh-size as far as the prepared surface allows. Mesh fixation optional with either absorbable sutures to the posterior sheath or with glubran glue. Closure of the anterior rectus sheath with a slowly-absorbable running suture. Skin closure. Dressing from xyphoid to pubis and 6 lateral dressings for blinding purposes.",[15],[28,32],{"name":29,"affiliation":30,"role":31},"Johannes Baur, MD","Clarunis - Universitäres Bauchzentrum Basel","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":30,"role":31},"Julian Süsstrunk, MD",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Fiorenzo Angehrn, MD","CONTACT","00 41 61 777 73 17","fiorenzo.angehrn@clarunis.ch",{"type":41,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[43,46],{"name":44,"class":45},"St. Clara Hospital, Basel, Switzerland","UNKNOWN",{"name":47,"class":45},"Klinikum Kempten, Kempten, Germany","100544086","open-versus-robotic-retromuscular-repair-in-medium-to-large-ventral-hernias-100544086",false,"NCT06364306","oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias","oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias - the PRIOR Multicentre Randomized Controlled Trial","PRIOR","Inclusion Criteria:\n\n* Patient age \\>18 years\n* Informed consent obtained\n* Transverse diameter of ventral hernia \\>4cm - 15cm\n* Eligible to open and minimally-invasive surgery according to preoperative anaesthetic assessment\n\nExclusion Criteria:\n\n* precedent hernia treatment with mesh placement in the retromuscular space\n* precedent anterior or posterior component separation or transversus abdominis release (TAR)\n* active wound infection\n* current cancer diagnosis\n* presence of ileostomy, colostomy or ileal conduit\n* liver disease defined by the presence of ascites\n* end-stage renal disease requiring dialysis\n* need of an emergency surgery\n* pregnancy\n\nCriteria for participating surgeons Each participating surgeon has performed 20 or more OVHR and RVHR.","ALL","18 Years",{"count":59,"type":60},140,"ESTIMATED","INTERVENTIONAL",[63],"NA","This study investigates on the effect of two different operative techniques to treat large abdominal wall defects.\n\nThe 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).\n\nThe main questions it aims to answer are:\n\nlength of stay after the operation rate of complications rate of recurrence and reoperations quality of life.\n\nParticipants will:\n\nEither be operated using the RVHR or OVHR will be followed up either in person or via email \u002F 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.",[66,67,68],"Ventral Hernia","Incisional Hernia","Abdominal Wall Defect","NOT_YET_RECRUITING","2025-04-15",{"date":72,"type":73},"2025-04-18","ACTUAL",{"date":75,"type":60},"2025-10-01",{"date":77,"type":60},"2031-12-31",{"name":5,"class":6}]