[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institut Catala de Salut\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"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":21,"type":22},250,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Ventral Incisional Hernia",[30,31,32,33,34,35],"Ventral hernia","Incisional hernia","Mesh","Glue","Tackers","IPOM plus","NOT_YET_RECRUITING","2024-03-04",{"date":39,"type":40},"2024-03-06","ACTUAL",{"date":42,"type":22},"2024-03-10",{"date":44,"type":22},"2026-12-31",{"name":46,"class":47},"Institut Catala de Salut","OTHER_GOV",""]