[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407932":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":28,"responsibleParty":39,"collaborators":43,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":28,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":28,"enrollmentInfo":61,"targetDuration":28,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":75,"whyStopped":28,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":28},{"fullName":5,"class":6},"Paracelsus Medical University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Sutures only","ACTIVE_COMPARATOR","Patients with a large hiatal hernia undergo the cruroplasty with sutures only.\n\nA large hiatal hernia is defined as \\> 5cm in manometry or gastroscopy or at least 1\u002F3 of the stomach lying intrathoracically.",[13],"Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet",{"label":15,"type":10,"description":16,"interventionNames":17},"Absorbable Mesh","Patients with a large hiatal hernia undergo the cruroplasty with mesh implantation.\n\nA large hiatal hernia is defined as \\> 5cm in manometry or gastroscopy or at least 1\u002F3 of the stomach lying intrathoracically.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Pledgeted sutures","Patients with a large hiatal hernia undergo the cruroplasty with pledgeted sutures.\n\nA large hiatal hernia is defined as \\> 5cm in manometry or gastroscopy or at least 1\u002F3 of the stomach lying intrathoracically.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet","Patients are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia.The hiatal closure will be done with sutures, pledgeted sutures or absorbable mesh (Phasix™ST mesh). After cruroplasty a fundoplication according to Toupet will be done additionally.",[15,19,9],null,[30,35],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Michael Weitzendorfer, MD, PhD","CONTACT","+435725551078","m.weitzendorfer@salk.at",{"name":36,"role":32,"phone":37,"phoneExt":28,"email":38},"Oliver O Koch, MD, FEBS","+435725551091","o.koch@salk.at",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Michael Weitzendorfer, MD","Dr. Michael Weitzendorfer, PhD",[44,46,48,50],{"name":45,"class":6},"Medical University Innsbruck",{"name":47,"class":6},"Medical University of Vienna",{"name":49,"class":6},"Krankenhaus Barmherzige Schwestern Linz",{"name":51,"class":6},"Elisabethinen Hospital","100407932","a-prospective-randomised-multi---center-trial-on-the-repair-of-large-hiatal-hernias-absorbable-mesh-vs-pledgeted-sutures-vs-sutures-only-100407932",false,"NCT04591860","A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only","A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh","Inclusion Criteria:\n\n* Patients with a large hiatal hernia - admitted for surgery (laparoscopic \u002F robot-assisted)\n* Written informed consent\n* ≥ 18 years of age\n* Hiatal hernia documented by barium x-ray and\u002For gastroscopy and\u002For manometry by one or more of the following criteria:\n\n  * \\> 5cm hiatal hernia\n  * 1\u002F3 of the stomach in the thorax\n\nExclusion Criteria:\n\n* Lack of patient consent for study participation\n* Lack of consent to study due to linguistic or mental incomprehension\n* Patients in poor general condition (lack of anesthesia ability)\n* Pregnancy\n* Prior surgery on the stomach or gastroesophageal junction\n* Simultaneous surgery because of another illness","ALL","18 Years",{"count":62,"type":63},165,"ESTIMATED","INTERVENTIONAL",[66],"NA","A prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable mesh\n\nThe primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh).\n\nThe duration of the study is not limited and depends on the number of cases planned. After enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.",[69],"Hiatal Hernia",[71,72,73,74],"hiatal hernia","pledgets","mesh","hernia recurrence","NOT_YET_RECRUITING","2024-04-01",{"date":78,"type":79},"2024-04-02","ACTUAL",{"date":81,"type":63},"2024-05-01",{"date":83,"type":63},"2027-05-01",{"name":5,"class":6}]