[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530212":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":31,"collaborators":25,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":37,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":25,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":62,"whyStopped":25,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":25},{"fullName":5,"class":6},"Institut Catala de Salut","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional","ACTIVE_COMPARATOR","Patients with a traumatic fixation of the mesh",[13],"Device: Conventional",{"label":15,"type":16,"description":17,"interventionNames":18},"Glutack","EXPERIMENTAL","Patient with Glutack mesh fixation",[19],"Device: Glutack",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Three ports are used (1x11 mm and 2x5 mm) and after adhesiolysis and the field prepared, the defect is measured with a local standard in a craneo-caudal and transversal directions. Then, the defect is closed with a 2-0 caliber barbed suture following its biggest axis. A Dynamesh IPOM previously hydrated (2-3 min) is introduced throughout the 11mm trocar and extended. After this maneuver, mesh fixation is performed depending on the randomized arm: Glutack",[15],null,{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"Three ports are used (1x11 mm and 2x5 mm) and after adhesiolysis and the field prepared, the defect is measured with a local standard in a craneo-caudal and transversal directions. Then, the defect is closed with a 2-0 caliber barbed suture following its biggest axis. A Dynamesh IPOM previously hydrated (2-3 min) is introduced throughout the 11mm trocar and extended. After this maneuver, mesh fixation is performed depending on the randomized arm: Traumatic fixation",[9],[30],"Traumatic fixation",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Rafael Villalobos Mori","Head of Abdominal Wall Unit Surgery","100530212","only-mesh-fixation-with-glue-of-ventralincisional-laparoscopic-hernia-repair-100530212",false,"NCT06183840","Only Mesh Fixation With Glue of Ventral\u002FIncisional Laparoscopic Hernia Repair","OMEGA Trial: A Multicenter Randomized Controlled Non-inferiority Trial of Only MEsh Fixation With a Glue Applicator Comparing Traumatic vs Atraumatic Fixation of the Mesh in Ventral\u002FIncisional Laparoscopic Repair","OMEGA","Inclusion Criteria:\n\n* All adults with a BMI lesser than 35 Kg\u002Fm2 undergoing an elective laparoscopic primary ventral or incisional hernia repair with a fascial transverse defect between 4-8 cm (W2 EHS) on anterior or lateral location (M1-M5 up to 10 cm of length or L1-3)\n* ASA grade from I-II\n* Informed consent signed\n\nExclusion Criteria:\n\n* Patients less than 18 years and over 80 years of age.\n* Fascial transverse defect less than 4 cm and more than 8 cm.\n* Recurrent ventral or incisional hernia in the same place\n* Emergency surgery\n* Procedure involving concomitant surgeries (e.g. gastrointestinal, biliary or genitourinary surgery)\n* BMI greater than 35 Kg\u002Fm2\n* ASA III-IV\n* Pregnancy\n* Tobacco","ALL","18 Years","80 Years",{"count":47,"type":48},250,"ESTIMATED","INTERVENTIONAL",[51],"NA","This multicenter randomized controlled non-inferiority trial of only mesh fixation with a glue applicator is a trial to evaluate the outcomes between atraumatic laparoscopic mesh fixation with GLUTACK-Glubran2® and conventional traumatic fixation, so the primary endpoint of the study is to analyze the recurrence on ventral or incisional hernia repair 2 years postoperatively assessed by a clinical and\u002For imaging technique.",[54],"Ventral Incisional Hernia",[56,57,58,59,60,61],"Ventral hernia","Incisional hernia","Mesh","Glue","Tackers","IPOM plus","NOT_YET_RECRUITING","2024-03-04",{"date":65,"type":66},"2024-03-06","ACTUAL",{"date":68,"type":48},"2024-03-10",{"date":70,"type":48},"2026-12-31",{"name":5,"class":6}]