[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100269049":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":63,"collaborators":66,"id":70,"slug":30,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":30,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":30,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":30,"overallStatus":48,"whyStopped":30,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Algemeen Ziekenhuis Maria Middelares","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"No-fixation","These patients will be randomized during the operation, at the time of mesh placement to receive the 3D ENDOLAP visible without fixation.",[12],"Procedure: No-fixation",{"label":14,"type":15,"description":16,"interventionNames":17},"LiquiBand Fix glue fixation","EXPERIMENTAL","These patients will be randomized during the operation, at the time of mesh placement to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation.\n\nPatients will be operated in a standard procedure to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation.",[18],"Procedure: LiquiBand Fix8 glue fixation",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","LiquiBand Fix8 glue fixation","Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation.",[14],[26],"LiquiBand Fix8 glue",{"type":21,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible without glue fixation.",[9],null,[32],{"name":33,"affiliation":5,"role":34},"Filip Muysoms, MD, PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","0032-92467400","FC","filip.muysoms@azmmsj.be",{"name":42,"role":37,"phone":43,"phoneExt":30,"email":44},"Iris Kyle-Leinhase, PhD","+3292467451","iris.kyle-leinhase@azmmsj.be",[46],{"facility":47,"status":48,"city":49,"state":30,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"AZ Maria Middelares","RECRUITING","Ghent","9000","Belgium","BE",{"type":54,"coordinates":55},"Point",[56,57],3.71667,51.05,{"lat":57,"lon":56},[60,62],{"name":42,"role":37,"phone":61,"phoneExt":30,"email":44},"92467451",{"name":33,"role":34,"phone":30,"phoneExt":30,"email":30},{"type":34,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Filip Muysoms","abdominal wall surgeon",[67],{"name":68,"class":69},"Duomed","INDUSTRY","100269049",false,"NCT02781870","Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible Mesh With or Without LiquiBand Fix 8 Mesh Fixation","Randomized Single-center Study on Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible With and Without LiquiBand Fix 8 Mesh Fixation","Inclusion Criteria:\n\n* adult patients presenting with primary unilateral inguinal hernia\n* patients planed for a laparoscopic repair\n\nExclusion Criteria:\n\n* Age below 18 years\n* recurrent or incarcerated hernias\n* open hernia repair and bilateral hernias\n* concomitant repair of another kind of abdominal hernia\n* combined surgical procedures\n* no informed consent\n* pregnant women\n* ASA score 4 or more\n* contra-indications for MRI scans.","ALL","18 Years","80 Years",{"count":80,"type":81},100,"ESTIMATED","INTERVENTIONAL",[84],"NA","This study aims to visualize the implanted mesh in vivo by MRI in 20 patients at 1 month and 12 months post-operatively. Moreover, we want to evaluate the safety and efficiency of non-penetration mesh fixation techniques using pre-designed ENDOLAP 3D visible mesh placement versus mesh fixation using a synthetic LiquiBand Fix 8 glue for laparoscopic treatment of groin hernias.\n\nA total of 100 male and female patients will be entered in the trial in Maria Middelares Ghent, for which an inclusion period of 24 months is anticipated. Four surgeons of the department of surgery will screen all eligible consecutive patients for inclusion in the study. They will inform all patients about the surgery and the follow-up with MRI scan thereafter.",[87,88],"Hernia","Recurrence","2025-04-10",{"date":91,"type":92},"2025-04-11","ACTUAL",{"date":94,"type":92},"2016-05-09",{"date":96,"type":81},"2027-08",{"name":5,"class":6},1]