[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650899":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":45,"responsibleParty":57,"collaborators":60,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":26,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":102,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University of Rome Tor Vergata","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mesh-repair group","EXPERIMENTAL","Patients randomized to this arm will receive prophylactic onlay placement of a biosynthetic mesh (poly-4-hydroxybutyrate mesh) to reinforce the abdominal wall closure at the time of laparotomy closure, in addition to standard surgical closure. A minimum overlap of 3 cm on all sides of the incision will be ensured. Mesh fixation will be achieved with four sutures placed at the cardinal points only.",[13],"Device: Prophylactic Biosynthetic Mesh Placement",{"label":15,"type":16,"description":17,"interventionNames":18},"Direct suture group","ACTIVE_COMPARATOR","Patients randomized to this arm will receive standard abdominal wall closure according to European Hernia Society (EHS) guidelines: a slowly absorbable running suture will be used in all centers, employing a continuous small-bites technique. Tissue bites of 5-9 mm from the wound edges will incorporate the aponeurosis only, with stitches placed 5 mm apart to ensure uniform tension distribution, aiming for a suture length to wound length ratio of at least 4:1.",[19],"Procedure: Direct suture",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Prophylactic Biosynthetic Mesh Placement","A biosynthetic mesh (poly-4-hydroxybutyrate mesh) is placed prophylactically to reinforce abdominal wall closure during laparotomy closure.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Direct suture","Direct fascial suture closure of the abdominal wall after laparotomy without prophylactic mesh reinforcement.",[15],[33],{"name":34,"affiliation":35,"role":36},"Andrea Divizia, MD, PhD","UOSD Chirurgia d'Urgenza, Policlinico di Roma Tor Vergata","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Andrea Martina Guida, MD","CONTACT","+390620908126","andreamartina.guida@ptvonline.it",{"name":34,"role":40,"phone":26,"phoneExt":26,"email":44},"andrea.divizia@ptvonline.it",[46],{"facility":47,"status":26,"city":48,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":26},"Policlinico di Roma Tor Vergata","Roma","Italy","IT",{"type":52,"coordinates":53},"Point",[54,55],11.10642,44.99364,{"lat":55,"lon":54},{"type":36,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Andrea Divizia","MD, PhD",[61,63,65,67,69,71,74],{"name":62,"class":6},"Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo",{"name":64,"class":6},"San Filippo Neri General Hospital",{"name":66,"class":6},"San Giovanni Addolorata Hospital",{"name":68,"class":6},"Santa Maria della Pieta Hospital - Nola",{"name":70,"class":6},"Buccheri La Ferla Hospital, Palermo",{"name":72,"class":73},"Cardarelli Hospital, Naples, Italy","UNKNOWN",{"name":75,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","100650899","prophylactic-mesh-reinforcement-versus-primary-closure-after-emergency-midline-laparotomy-preempt-100650899",false,"NCT07753551","Prophylactic Mesh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT)","PRophylactic mEsh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT): A Multicenter Randomized Clinical Trial","PREEMPT","Inclusion Criteria:\n\nAll adult patients (≥18 years) undergoing emergency midline laparotomy will be eligible for inclusion, without upper age limit, to reflect real-world clinical practice.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Minimally invasive surgery (laparoscopic or robotic approaches)\n* Elective surgery\n* Surgery requiring an open abdomen and its closure\n* Fecal peritonitis\n* Previous midline laparotomy\n* Pregnancy or breastfeeding\n* Conditions that would impair the possibility of understanding and giving of informed consent.","ALL","18 Years",{"count":87,"type":88},189,"ESTIMATED","INTERVENTIONAL",[91],"NA","The PREEMPT trial is a multicenter randomized controlled trial comparing prophylactic onlay biosynthetic mesh reinforcement with primary suture closure in adult patients undergoing emergency midline laparotomy. Participants will be randomized in a 1:1 ratio. The primary endpoint is the incidence of incisional hernia at 1 year. Secondary endpoints include postoperative complications, surgical site occurrences, pain, operative time, hospital stay, morbidity, mortality, quality of life, and long-term hernia incidence.",[94,95],"Incisional Hernia After Midline Laparotomy","Emergency Abdominal Surgery",[97,98,99,100,101],"incisional hernia","laparotomy","emergency","primary prevention","surgical mesh","NOT_YET_RECRUITING","2026-08-05",{"date":105,"type":106},"2026-08-07","ACTUAL",{"date":108,"type":88},"2026-09-01",{"date":110,"type":88},"2031-08-31",{"name":5,"class":6},1]