[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614491":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":18,"responsibleParty":36,"collaborators":18,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":18,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":18,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":63,"whyStopped":18,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":18},{"fullName":5,"class":6},"Federico II University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Anti-adhesion gel group","EXPERIMENTAL","Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure.",[13],"Device: Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care group","NO_INTERVENTION","Women will not receive any anti-adhesion methods",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure","The difference compared to other studies published in the past is that, in our trial, at the end of the robotic myomectomy-which will be performed using the same technique in both groups-an anti-adhesion gel will be applied in the intervention group to prevent the formation of intrauterine adhesions.",[9],[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Brunella Zizolfi, Dr.","CONTACT","+39 3381651272","+39","brunellazizolfi@hotmail.it",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Danilo Borrelli, Dr.","+39 3488277581","danil.borrelli@gmail.com",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Brunella Zizolfi","PhD, MD","100614491","incidence-of-intrauterine-adhesions-after-myomectomy-with-intrauterine-anti-adhesion-gel-100614491",false,"NCT07280286","Incidence of Intrauterine Adhesions After Myomectomy With Intrauterine Anti-Adhesion Gel","Incidence of Intrauterine Adhesions Following Myomectomies With the Use of an Intrauterine Anti-adhesion Gel","Inclusion Criteria:\n\n* Age between 18 and 45 years;\n* BMI 18-35;\n* One or more fibroids diagnosed via ultrasound;\n* First myomectomy or uterine surgery;\n* Incomplete reproductive plans and\u002For infertility;\n* Adequate immune, respiratory, liver, cardiac, bone marrow, and kidney function;\n* Compliance and psychological ability to follow study procedures;\n* Acceptance and signing of informed consent.\n\nExclusion Criteria:\n\n* Age under 18 years;\n* Age over 46 years;\n* Pregnancy or breastfeeding;\n* History of intrauterine adhesions;\n* Diagnosis or suspicion of malignant gynecological pathologies and\u002For autoimmune diseases;\n* Completed reproductive plans;\n* Severe respiratory, bone marrow, liver, or kidney dysfunction preventing safe surgical access.","FEMALE","18 Years","45 Years",{"count":51,"type":52},62,"ESTIMATED","INTERVENTIONAL",[55],"NA","This prospective randomized study aims to evaluate whether the application of an intrauterine anti-adhesion gel reduces the incidence of intrauterine adhesions (IUAs) following robotic-assisted laparoscopic myomectomy. Intrauterine adhesions may develop after endometrial trauma during surgery and can negatively affect menstrual function, fertility, and future pregnancy outcomes. Robotic myomectomy offers a minimally invasive approach, but postoperative adhesion formation remains a concern.\n\nSixty-two women undergoing myomectomy will be randomized to receive either intrauterine anti-adhesion gel (intervention group) or no adhesion-prevention method (control group). Adhesions will be assessed by ultrasound and hysteroscopy during follow-up. Secondary outcomes include reproductive results over a 24-month period, such as implantation rate, clinical pregnancy, miscarriage, live birth, pregnancy complications, and neonatal outcomes.\n\nThe study seeks to determine whether combining a minimally invasive surgical approach with an intrauterine gel provides additional protection against adhesion formation and improves fertility-related outcomes.",[58,59],"Myoma;Uterus","Adhesion; Uterus, Internal",[61,62],"intrauterine adhesions","myomectomy","NOT_YET_RECRUITING","2025-12-03",{"date":66,"type":67},"2025-12-12","ACTUAL",{"date":69,"type":52},"2025-12-09",{"date":71,"type":52},"2028-11-20",{"name":5,"class":6}]