[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597743":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":30,"studyPopulation":31,"armGroups":32,"interventions":46,"overallOfficials":52,"centralContacts":57,"locations":62,"responsibleParty":79,"collaborators":26,"id":82,"slug":26,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":26,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":26,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":64,"whyStopped":26,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Candiolo Cancer Institute - IRCCS","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"measurement of nipple sensation preservation","The primary objective, the measurement of nipple sensation preservation, will be conducted using the Semmes-Weinstein esthesiometer. The clinician will use the device to touch the nipple and the surrounding quadrants of the skin, applying filaments of increasing calibers (0.07gr, 0.4gr, 2.0gr, 4.0gr, 300gr), and the lightest caliber perceived by the patient will be recorded.","This assessment will be conducted at four different times: • Before surgery, to assess baseline sensation. • 1 month after surgery. • 3 months after surgery. • 6 months after surgery.",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"surgical outcomes","nipple-areola complex necrosis, skin flaps necrosis, infection, bleeding, seroma, wound dehiscence,","from enrollment to 3 months",{"measure":19,"description":20,"timeFrame":21},"anatomopathological findings","the presence or absence of sensory cutaneous receptors in the subcutaneous layer of the specimen and their possible correlation to the degree of cutaneous sensation","30-60 days post-surgery",{"measure":23,"description":24,"timeFrame":25},"PROMs","Questionnaires will be administered to the patients to assess patient-reported outcomes: Hopwood Body Image Scale (score 0 to 30, higher scores meaning a worst outcome), and EORTC - European Organisation for Research and Treatment of Cancer, BR-23 questionnaire (no total score, each question compared individually between groups)","From enrollment to 6 monts postoperatively",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"COHORT","PROSPECTIVE","The NIPSENSE study is a prospective, single-center study comparing how well nipple sensation is preserved after three types of nipple-sparing mastectomy (NSM): Conventional NSM (C-NSM), Endoscopic NSM (E-NSM), and Robotic NSM (R-NSM). The goal is to better understand the sensory and quality-of-life outcomes associated with each technique.\n\nA total of 90 female participants (30 in each group) will be recruited. All will undergo NSM with direct-to-implant reconstruction. Participants will be assessed for nipple and skin sensation before surgery, and again at 1, 3, and 6 months after surgery, using a standard medical tool called the Semmes-Weinstein esthesiometer.\n\nThe study will also evaluate:\n\nSurgical complications (e.g., infection, bleeding, skin necrosis)\n\nPatient-reported outcomes using validated tools like the Hopwood Body Image Scale and EORTC questionnaires\n\nTissue analysis to explore whether preserved nerve structures are related to the level of sensation after surgery\n\nThis study will provide important data about how surgical methods impact physical and emotional outcomes for people undergoing mastectomy. The findings may help improve patient care and inform future decisions about surgical approaches to breast cancer treatment.","The study population will consist of female patients aged 18 years or older, eligible for mastectomy for early-stage breast cancer or high-risk conditions, who meet the study eligibility criteria. A total of 90 patients will be recruited at Candiolo Cancer Institute in Torino (Italy).",[33,38,42],{"label":34,"type":26,"description":35,"interventionNames":36},"Conventional Nipple-Sparing Mastectomy (C-NSM)","Participants in this group will undergo a standard open nipple-sparing mastectomy using traditional surgical instruments. The procedure is performed through a visible incision on the breast, while preserving the nipple and surrounding skin. An implant is placed for immediate reconstruction.",[37],"Diagnostic Test: Nipple Sensation Assessment",{"label":39,"type":26,"description":40,"interventionNames":41},"Endoscopic Nipple-Sparing Mastectomy (E-NSM)","This group will receive a minimally invasive nipple-sparing mastectomy using an endoscopic technique. The breast tissue is removed through a small incision in the armpit using a camera and specialized instruments. An implant is placed during the same surgery",[37],{"label":43,"type":26,"description":44,"interventionNames":45},"Robotic Nipple-Sparing Mastectomy (R-NSM)","Participants in this group will undergo a robotic-assisted nipple-sparing mastectomy. The surgery is performed using a robotic surgical system through a small armpit incision, offering enhanced precision and visualization. Immediate implant reconstruction is also performed.",[37],[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":26},"DIAGNOSTIC_TEST","Nipple Sensation Assessment","the measurement of nipple sensation preservation, will be conducted using the Semmes-Weinstein esthesiometer. The clinician will use the device to touch the nipple and the surrounding quadrants of the skin, applying filaments of increasing calibers (0.07gr, 0.4gr, 2.0gr, 4.0gr, 300gr), and the lightest caliber perceived by the patient will be recorded. This assessment will be conducted at four different times:\n\n* Before surgery, to assess baseline sensation.\n* 1 month after surgery.\n* 3 months after surgery.\n* 6 months after surgery.",[34,39,43],[53],{"name":54,"affiliation":55,"role":56},"Giada Pozzi, MD","Candiolo Cancer Institute FPO-IRCCS","PRINCIPAL_INVESTIGATOR",[58],{"name":54,"role":59,"phone":60,"phoneExt":26,"email":61},"CONTACT","+39 011 9933017","giada.pozzi@ircc.it",[63],{"facility":55,"status":64,"city":65,"state":26,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"RECRUITING","Torino","10060","Italy","IT",{"type":70,"coordinates":71},"Point",[72,73],11.99138,44.88856,{"lat":73,"lon":72},[76],{"name":55,"role":59,"phone":77,"phoneExt":26,"email":78},"+39 0119933111","social@ircc.it",{"type":56,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Giada Pozzi","MD","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":92,"type":93},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)",[97],"Sensation Disorder",[99,100,101,102,103,104,105,106,107,108,109],"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","2025-07-10",{"date":112,"type":113},"2025-07-14","ACTUAL",{"date":115,"type":113},"2025-06-01",{"date":117,"type":93},"2027-12-01",{"name":5,"class":6},1]