[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491739":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":31,"studyPopulation":18,"armGroups":32,"interventions":43,"overallOfficials":18,"centralContacts":51,"locations":59,"responsibleParty":80,"collaborators":82,"id":86,"slug":18,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":18,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":62,"whyStopped":18,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Adhesion formation postoperatief.","The presence of intra-uterine adhesions on a second look hysteroscopy.","3 months post surgery",[14],{"measure":15,"description":16,"timeFrame":17},"Severity of adhesion formation","American Fertility Society classification (AFS) and classification of Valle and Sciarra are used to describe the severity.","3 months post surgery, at the time of the hysteroscopy.",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions. The application of antiadhesion gel is compared to no gel.","PREVENTION",{"masking":25,"maskingDescription":26,"whoMasked":27},"TRIPLE","None of the participants will be informed of the allocated treatment by the surgeon or the personnel present in the OR. The medical record will not reveal any information whether antiadhesion gel was applied at the end of the procedure. In the case that the surgeon is the same person as the gynaecologist doing the second-look hysteroscopy, blinding is assured by notification of treatment allocation if the surgeon has left the operating room.",[28,29,30],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","Design:\n\nDouble-blind, randomized controlled pilot trial.\n\nParticipant:\n\n* age between 18 and 45 years.\n* intramurale and\u002For subserosal myoma (FIGO 3-6), and\u002For hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic \u002F laparotomic myomectomy.\n* absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy\n\nTreatment:\n\nApplication of intrauterine Hyalobarrier® gel endo at time of surgery\n\nControl:\n\nNo application of Hyalobarrier® gel endo\n\nFollow up:\n\nSecond-look hysteroscopy after 3months\n\nTo blind all trial participants and gynaecologists doing second-look hysteroscopy, 10 ml of a sterile ultrasound gel will be applied into the vagina at the end of the procedure in all women regardless of their treatment allocation.",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"intrauterine gel application","EXPERIMENTAL","Application of Hyalobarrier intrauterine after myomectomy.",[38],"Device: Hyalobarrier",{"label":40,"type":41,"description":42,"interventionNames":18},"no intra-uterine gel application","NO_INTERVENTION","No application of Halobarrier intrauterine after myomectomy.",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DEVICE","Hyalobarrier","Hyalobarrier is a viscous, transparent gel and is used as a preventive measure for post-operative adhesions in the abdominal and uterine cavity.",[34],[50],"anti-adhesive gel",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":18,"email":56},"Steffi Van Wessel, Dr.","CONTACT","093320758","studieco.vrouwenkliniek@uzgent.be",{"name":58,"role":54,"phone":55,"phoneExt":18,"email":56},"Steven Weyers, Prof. dr.",[60],{"facility":61,"status":62,"city":63,"state":18,"zip":18,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"University Hospital Ghent","RECRUITING","Ghent","Belgium","BE",{"type":67,"coordinates":68},"Point",[69,70],3.71667,51.05,{"lat":70,"lon":69},[73,75,77],{"name":74,"role":54,"phone":55,"phoneExt":18,"email":18},"Steffi van Wessel, Dr.",{"name":76,"role":54,"phone":55,"phoneExt":18,"email":18},"Steven Weyers, Prof. Dr.",{"name":78,"role":79,"phone":18,"phoneExt":18,"email":18},"Steffi van Wessel","PRINCIPAL_INVESTIGATOR",{"type":81,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[83],{"name":84,"class":85},"Nordic Pharma SAS","INDUSTRY","100491739",false,"NCT05683041","Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy","PALLM","Inclusion Criteria:\n\n* age between 18 and 45 years.\n* intramurale and\u002For subserosal myoma (FIGO 3-6), and\u002For hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic \u002F laparotomic myomectomy.\n* absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy\n\nExclusion Criteria:\n\n* pregnancy.\n* laparoscopic or laparotomic myomectomy in combination with an operative hysteroscopy.\n* presence of endometritis.\n* other antiadhesion methods",true,"FEMALE","18 Years","45 Years",{"count":97,"type":98},30,"ESTIMATED","INTERVENTIONAL",[101],"NA","Clinical study on the prevention of intrauterine adhesions after laparoscopic or laparotomic myomectomy.\n\nMyomas are common in women of reproductive age and myomectomy can lead to intra-uterine adhesions, which can be detrimental to fertility. This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions.",[104],"Myoma",[106,107,108,109,110,111,112],"Postoperative adhesions","Intrauterine adhesions","Myomectomy","Laparoscopic myomectomy","Laparotomic myomectomy","Adhesion prevention","Antiadhesion method","2025-01-22",{"date":115,"type":116},"2025-01-27","ACTUAL",{"date":118,"type":116},"2023-02-22",{"date":120,"type":98},"2028-01",{"name":5,"class":6},1]