[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571836":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":55,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":25,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":25,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Kuopio University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nissen fundoplication","ACTIVE_COMPARATOR","Hiatal hernia repair and Nissen (posterior 360-degree) fundoplication",[13],"Procedure: Nissen fundoplication",{"label":15,"type":16,"description":17,"interventionNames":18},"Dor fundoplication","EXPERIMENTAL","Hiatal hernia repair and Dor (anterior 180-degree) fundoplication",[19],"Procedure: Dor fundoplication",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Hiatal hernia repair and Nissen fundoplication",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Hiatal hernia repair and Dor fundoplication",[15],[30],{"name":31,"affiliation":5,"role":32},"Ville Palomäki, MD, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","+35817 173 311","Ville.Palomaki@pshyvinvointialue.fi",[39],{"facility":5,"status":40,"city":41,"state":25,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Kuopio","70200","Finland","FI",{"type":46,"coordinates":47},"Point",[48,49],27.67703,62.89238,{"lat":49,"lon":48},[52],{"name":53,"role":35,"phone":25,"phoneExt":25,"email":54},"Ville A. Palomäki, MD, PhD","Ville.Palomaki@pshyvinvoitialue.fi",{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100571836","nissen-versus-dor-hiatal-hernia-repair-100571836",false,"NCT06725433","Nissen Versus Dor Hiatal Hernia Repair","NiDor-study: a Randomized Controlled Trial Comparing Nissen and Dor Fundoplication in Hiatal Hernia Repair","NiDor","Inclusion Criteria:\n\n* At least 18 years of age\n* Type II-IV hiatal hernia, confirmed by radiology or endoscopy\n* Scheduled for mini-invasive hiatal hernia repair\n* Emergency mini-invasive surgery for hiatal hernia\n* The informed consent is acquired\n\nExclusion Criteria:\n\n* Recurrent hiatal hernia\n* Need for esophageal lengthening procedure (Collis)\n* Gangrene or need for any resection during (emergency) surgery\n* Need for laparotomy or thoracotomy\u002Fthoracoscopy\n* No written consent","ALL","18 Years",{"count":68,"type":69},150,"ESTIMATED","INTERVENTIONAL",[72],"NA","Hiatal hernia can present with a wide range of symptoms. An usual surgical repair technique usually includes Nissen fundoplication, while other procedures are less frequently employed. However, recurrence and reoperation rates remain high. This randomized controlled trial aims to compare the efficacy of Nissen and Dor fundoplication in preventing hiatal hernia recurrence and reducing the risk of reoperation\n\nParticipants undergoing minimally invasive hiatal hernia repair will be randomly assigned to either Nissen or Dor fundoplication. Postoperatively at 12 months, anatomical recurrence rates based on computed tomography scans and symptomatic recurrence rates, anti-reflux medication use, GERD-related quality of life, and dysphagia symptoms will be assessed. A subsequent long-term follow-up study will conducted afterwards utilizing national registry data to evaluate reoperation rates and anti-reflux medication use",[75,76,77],"Hiatal Hernia","Paraesophageal Hernia","Recurrence","2025-02-17",{"date":80,"type":81},"2025-02-19","ACTUAL",{"date":83,"type":81},"2025-02-07",{"date":85,"type":69},"2030-01-30",{"name":5,"class":6},1]