[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sensation-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sensation-disorder":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100597743",false,"NCT07062458","A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques","NIPSENSE - A Comparative Study of Nipple and Skin Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, and Robotic Techniques","NIPSENSE","Inclusion Criteria:\n\n* Female patients aged ≥18 years.\n* Diagnosed with early-stage breast cancer or deemed at high risk for breast cancer (eg. BRCA1-2 mutations).\n* Candidates for Nipple-Sparing Mastectomy (NSM).\n* Able to provide informed consent.\n* No contraindications for surgery based on physical examination and preoperative assessment.\n* Signed the consent forms and willing to participate in all scheduled follow-up assessments.\n\nExclusion Criteria:\n\n* Previous breast surgery.\n* History of radiation therapy to the chest\u002Fbreast area.\n* Active or non-controlled diabetes mellitus.\n* Neuropathies causing potentially altered skin sensation.\n* Nipple involvement by cancer, clinical or reported intra-operatively via frozen section analysis (the procedure will be converted to SSM).","FEMALE","18 Years",{"count":19,"type":20},90,"ESTIMATED","OBSERVATIONAL","The goal of this comparative study is to learn how different surgical methods affect nipple and skin sensation after nipple-sparing mastectomy (NSM). The study will compare three types of NSM: conventional, endoscopic, and robotic.\n\nThe main question it aims to answer is:\n\nHow much nipple sensation do participants keep after each type of surgery?\n\nResearchers will also look at surgery-related complications, patient-reported outcomes like body image and quality of life, and tissue analysis to see if there is a link between nerve structures and sensation.\n\nParticipants will:\n\nHave NSM using one of the three surgical approaches\n\nReceive breast reconstruction with an implant during the same surgery\n\nComplete nipple sensation tests before and at 1, 3, and 6 months after surgery\n\nAnswer surveys about their quality of life and body image\n\nProvide surgical tissue for analysis (as part of the planned procedure)",[24],"Sensation Disorder",[26,27,28,29,30,31,32,33,34,35,36],"Nipple sensation","Sensory outcomes","Quality of life","Endoscopic breast surgery","Robotic breast surgery","Breast cancer surgery","Nipple-sparing mastectomy","Breast reconstruction","R-NSM","E-NSM","conventional mastectomy","RECRUITING","2025-07-10",{"date":40,"type":41},"2025-07-14","ACTUAL",{"date":43,"type":41},"2025-06-01",{"date":45,"type":20},"2027-12-01",{"name":47,"class":48},"Candiolo Cancer Institute - IRCCS","OTHER",""]