[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581592":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":44,"studyPopulation":44,"armGroups":50,"interventions":61,"overallOfficials":44,"centralContacts":67,"locations":77,"responsibleParty":109,"collaborators":112,"id":114,"slug":44,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":44,"eligibilityCriteria":118,"healthyVolunteers":115,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":44,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":80,"whyStopped":44,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"University Children's Hospital, Zurich","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative change of AMH level","Change in AMH level postoperatively compared to preoperative AMH levels (measured in pmol\u002FL).","8 weeks",[14],{"measure":15,"description":16,"timeFrame":17},"Postoperative recurrence rate","Postoperative recurrence is defined as an ipsilateral asymptomatic cyst ≥ 4cm or a cyst of any size that requires a medical or surgical intervention due to symptoms at follow-up 6-8 weeks postoperatively.\n\nIf the asymptomatic cyst is \\\u003C 4cm, a second follow-up will be performed at 10-14 weeks postoperatively. Recurrence is then defined as ipsilateral asymptomatic cyst ≥ 4cm or a cyst of any size that requires a medical or surgical intervention due to symptoms.\n\nThe outcome will be measured as \"recurrence\u002Fno recurrence\"","14 weeks",[19,23,26,29,32,35,38],{"measure":20,"description":21,"timeFrame":22},"Intraoperative complications","The investigators will describe any intraoperative complications.","2 weeks",{"measure":24,"description":25,"timeFrame":22},"Operative times","The investigators will measure the operative times in minutes for both techniques.",{"measure":27,"description":28,"timeFrame":17},"Postoperative ipsilateral ovarian volume on ultrasound","The postoperative ipsilateral ovarian volume will be calculated by ultrasound (Ovarian Volume: V (in ml) = long axis in cm x transversal axis x ap diameter x 0.5) and compared to published standard ovarian volumes in ml according to age.",{"measure":30,"description":31,"timeFrame":17},"Postoperative adnexal ratio","The adnexal ratio will be calculated by division of the volume of the affected ovary (in ml) with the volume of the unaffected ovary (in ml). If the adnexal ratio is \\\u003C1 postoperatively, this can be a sign of postoperative volume loss.",{"measure":33,"description":34,"timeFrame":12},"Postoperative histology","The investigators will assess the histology of the cyst wall according to the following entities: functional cyst\u002F serous cystadenoma\u002F mucinous cystadenoma\u002F other entity.",{"measure":36,"description":37,"timeFrame":17},"Postoperative microscopic follicle count","The investigators will count the number of follicles that were removed on a representative sample of the surgical specimen, which will contain cyst wall +\u002F- ovarian cortex.",{"measure":39,"description":40,"timeFrame":17},"Postoperative complications","Postoperative complications will be described by the Clavien-Madadi Classification.",{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":44,"timePerspective":44,"maskingInfo":46},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":47,"maskingDescription":44,"whoMasked":48},"SINGLE",[49],"PARTICIPANT",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Ovarian Cyst Deroofing","EXPERIMENTAL","The Ovarian cyst is deroofed with a specific, predefined technique: removal of a square of the cyst wall and overlying ovarian capsule of 16x16mm and suctioning of cyst contents.",[56],"Procedure: Laparoscopic ovarian cyst surgery",{"label":58,"type":53,"description":59,"interventionNames":60},"Ovarian Cyst Enucleation","The ovarian cyst is enucleated by complete removal of the cyst lining with preservation of surrounding ovarian tissue.",[56],[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":44},"PROCEDURE","Laparoscopic ovarian cyst surgery","Laparoscopic ovarian cyst surgery is any surgery with the goal of removal or drainage of an ovarian cyst. The exact surgical technique will be predefined by randomization.",[52,58],[68,73],{"name":69,"role":70,"phone":71,"phoneExt":44,"email":72},"Uchenna Kennedy, MD","CONTACT","0041 2494949","uchenna.kennedy@kispi.uzh.ch",{"name":74,"role":70,"phone":75,"phoneExt":44,"email":76},"Ueli Möhrlen, Prof. Dr. med.","00412494949","ueli.möhrlen@kispi.uzh.ch",[78,97],{"facility":79,"status":80,"city":81,"state":44,"zip":44,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"University Children's Hospital Basel","RECRUITING","Basel","Switzerland","CH",{"type":85,"coordinates":86},"Point",[87,88],7.57327,47.55839,{"lat":88,"lon":87},[91,95],{"name":92,"role":70,"phone":93,"phoneExt":44,"email":94},"Ulrike Subotic, MD","+41617041212","ulrike.subotic@ukbb.ch",{"name":92,"role":96,"phone":44,"phoneExt":44,"email":44},"PRINCIPAL_INVESTIGATOR",{"facility":98,"status":80,"city":99,"state":44,"zip":44,"country":82,"countryCode":83,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"University Children's Hospital Zurich","Zurich",{"type":85,"coordinates":101},[102,103],8.55,47.36667,{"lat":103,"lon":102},[106,108],{"name":69,"role":70,"phone":107,"phoneExt":44,"email":72},"+412494949",{"name":69,"role":96,"phone":44,"phoneExt":44,"email":44},{"type":96,"investigatorFullName":110,"investigatorTitle":111,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Uchenna Kennedy","Principal Investigator",[113],{"name":79,"class":6},"100581592",false,"NCT06852313","Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents","Inclusion Criteria:\n\n* Symptomatic simple cysts ≥ 4 cm with indication for surgical intervention\n* Asymptomatic cysts ≥ 4 cm, with surgical indication due to persistence or increase in size\n* Asymptomatic cysts ≥ 4 cm with other pathology as surgical indication, if known preoperatively\n* Age 12 months - 18 years\n* Parents\u002Flegal custodian and patient give consent, for patients unable to consent due to their health condition or developmental status they show no signs of unwillingness to participate\n* Symptomatic simple cysts ≥ 4 cm with indication for surgical intervention on both ovaries (each ovary will count as one)\n\nExclusion Criteria:\n\n* Neonatal ovarian cysts (age \\\u003C12 months)\n* Age \\>18 years\n* Complex cysts (with solid components, e.g., Teratoma, risk or suspicion of malignancy)\n* Paratubar\u002Fparaovarian cysts\n* Medical reason that precludes cyst enucleation (e.g. severe coagulopathy)\n* Neither signed informed consent form or inadequate german, french or english language skills to give informed consent","FEMALE","1 Year","18 Years",{"count":123,"type":124},80,"ESTIMATED","INTERVENTIONAL",[127],"NA","The purpose of this study is to evaluate which operative technique should be used for managing simple ovarian cysts in girls and adolescents. The two techniques that are being compared are laparoscopic cyst enucleation and laparoscopic cyst deroofing. The investigators will assess the effect of both techniques on the ovarian reserve and the risk of cyst recurrence.",[130],"Ovarian Cyst Benign",[132,133,134],"Ovarian cyst","Laparoscopy","Child","2026-04-27",{"date":137,"type":138},"2026-04-28","ACTUAL",{"date":140,"type":138},"2026-02-05",{"date":142,"type":124},"2028-12-01",{"name":5,"class":6},2]