[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505610":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":39,"studyPopulation":29,"armGroups":40,"interventions":53,"overallOfficials":29,"centralContacts":63,"locations":70,"responsibleParty":83,"collaborators":85,"id":95,"slug":29,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":29,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":29,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":29,"overallStatus":113,"whyStopped":29,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Kuopio University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Chronic pain","Postoperative inguinal pain (vas scores 0-10) after 1 week, 4 weeks and one year of surgery","from 1 week to one year",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Complications","Postoperative complications of surgery (wound infection, hemorrhage)","1 month",{"measure":19,"description":20,"timeFrame":21},"Recurrence","Hernia recurrences after 5 years","5 years",{"measure":23,"description":24,"timeFrame":25},"Sick leave","how many days the patient is not working after surgery","0-30 days",{"measure":27,"description":28,"timeFrame":25},"Treatment costs","how much in euros the surgical treatment will cost",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"RANDOMIZED","PARALLEL","Randomized follow-up study","TREATMENT",{"masking":36,"maskingDescription":29,"whoMasked":37},"SINGLE",[38],"OUTCOMES_ASSESSOR","The best operative technique in female inguinal hernia is not known. Some register studies recommend always laparoscopic hernia repair in females, but there are no randomized studies to show that laparoscopic repair is better than open hernioplasty. Our study compares operative complications, chronic pain and recurrences in Lichtenstein operation to totally endoscopic hernia repair (TEP) in 170 female patients with primary inguinal hernia. The patients are operated in six Finnish hospitals, randomized into 85 Lichtenstein vs 85 TEP and followed 1 week, 4 weeks, 12 months and 5 years. Main end-point in postoperative pain after one year, sencondary endpoints are sick leave, return to normal physical activity, complications of treatment, re-operations, chronic pain and costs of treatment.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Open hernioplasty","EXPERIMENTAL","Open Lichtenstein hernia repair",[46],"Procedure: Open hernioplasty",{"label":48,"type":49,"description":50,"interventionNames":51},"TEP hernioplasty","ACTIVE_COMPARATOR","totally endoscopic hernia repair (TEP)",[52],"Procedure: TEP hernioplasty",[54,59],{"type":55,"name":42,"description":56,"armGroupLabels":57,"otherNames":58},"PROCEDURE","Inguinal hernia is operated using open surgery",[42],[44],{"type":55,"name":48,"description":60,"armGroupLabels":61,"otherNames":62},"Inguinal hernia is operated using laparoendoscopic technique",[48],[50],[64],{"name":65,"role":66,"phone":67,"phoneExt":68,"email":69},"Hannu EK Paajanen, MD","CONTACT","0405263101","+358","paajanen@surffi.fi",[71],{"facility":72,"status":29,"city":73,"state":29,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":29},"Mikkeli Central Hospital","Mikkeli","50100","Finland","FI",{"type":78,"coordinates":79},"Point",[80,81],27.27227,61.68857,{"lat":81,"lon":80},{"type":84,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[86,88,90,92,94],{"name":87,"class":6},"Helsinki University Central Hospital",{"name":89,"class":6},"Päijänne Tavastia Central Hospital",{"name":91,"class":6},"North Karelia Central Hospital",{"name":93,"class":6},"Jyväskylä Central Hospital",{"name":72,"class":6},"100505610",false,"NCT05863624","Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia","Postoperative Pain and Recurrences After Totally Extraperitoneal Endoscopic (TEP) vs. Lichtenstein Hernioplasty in Female Inguinal Hernia Repair: a Prospective Randomized Multi-center Study","Inclusion Criteria:\n\n* primary inguinal hernia in females\n\nExclusion Criteria:\n\n* emergency operation\n* recurrent hernia\n* groin pain without hernia\n* frail and sick patient ASA ≥ 4","FEMALE","18 Years","80 Years",{"count":105,"type":106},170,"ESTIMATED","INTERVENTIONAL",[109],"NA","This randomized study compares open inguinal hernia repair (Lichtenstein hernioplasty) to endoscopic repair (TEP) in terms of chronic pain and recurrences in one and five years after operation.",[112],"Post Operative Pain","NOT_YET_RECRUITING","2024-03-05",{"date":116,"type":117},"2024-03-06","ACTUAL",{"date":119,"type":106},"2024-09-01",{"date":121,"type":106},"2029-12-31",{"name":5,"class":6},1]