[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658229":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":15,"studyPopulation":15,"armGroups":68,"interventions":80,"overallOfficials":15,"centralContacts":90,"locations":96,"responsibleParty":112,"collaborators":15,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":15,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":15,"maxAge":15,"enrollmentInfo":124,"targetDuration":15,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":142,"whyStopped":15,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Guangzhou Women and Children's Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":15},[9,13],{"measure":10,"description":11,"timeFrame":12},"Tactile pressure sensation of the nipple-areola complex at 6 months postoperatively","Tactile pressure sensation will be measured using Semmes-Weinstein monofilaments. The examiner will apply the device to the nipple-areola complex, using filaments of incrementally increasing force (0.07 g, 0.4 g, 2.0 g, 4.0 g, 300 g), and record the lightest filament detectable by the patient.","12 months postoperatively",{"measure":14,"description":15,"timeFrame":16},"Positive surgical margin rate",null,"Intraoperative \u002F postoperative (2 weeks after surgery)",[18,22,25,28,31,35,38,41,45,48,52,55,58],{"measure":19,"description":20,"timeFrame":21},"Tactile pressure sensation of the nipple-areola complex and breast skin at multiple postoperative time points","Tactile pressure sensation will be measured using Semmes-Weinstein monofilaments. The examiner will apply the device to the nipple-areola complex and predefined quadrants of the surrounding breast skin, using filaments of incrementally increasing force (0.07 g, 0.4 g, 2.0 g, 4.0 g, 300 g), and record the lightest filament detectable by the patient.","Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively",{"measure":23,"description":24,"timeFrame":21},"Temperature sensation of the nipple-areola complex and breast skin","Temperature sensation will be assessed at the nipple-areola complex and predefined quadrants of the breast skin. Cold sensation is tested with an ice hammer, and warm sensation is tested using the heating mode of a massage device.",{"measure":26,"description":27,"timeFrame":21},"Erection function of the nipple-areola complex","Nipple erection function will be evaluated by stimulation of the nipple-areola complex using the vibration mode of a massage device.",{"measure":29,"description":30,"timeFrame":21},"Patient-reported outcomes","Patient-reported breast-specific sensory function, quality of life and sexual well-being will be assessed using the BREAST-Q™ Sensation Module (Pre- and Postoperative) Version 2.0 and BREAST-Q™ Breast Cancer Core Scale (Pre- and Postoperative) Version 2.0 (Sexual Well-being subscale). All subscales yield Rasch-transformed scores ranging from 0 (worst outcome) to 100 (best outcome): higher scores represent better breast sensory function, fewer breast symptoms, less negative quality-of-life impact from breast sensation alteration, and superior sexual well-being, respectively.",{"measure":32,"description":33,"timeFrame":34},"Disease-free survival (DFS)","Disease-free survival (DFS), defined as the time from surgery to the first occurrence of recurrence, metastasis, or death. DFS will be compared between the two study groups.","Following surgery up to 3 years",{"measure":36,"description":37,"timeFrame":34},"Overall survival (OS)","Overall survival (OS), defined as the time from surgery to death from any cause. OS will be compared between the two study groups.",{"measure":39,"description":40,"timeFrame":34},"Recurrence and Metastasis Events","The incidence of axillary recurrence, locoregional recurrence, and distant metastasis is compared between the two groups, with all events confirmed by histopathological or radiological evidence.",{"measure":42,"description":43,"timeFrame":44},"Postoperative Complications","The incidence of postoperative complications, including but not limited to: nipple-areola complex necrosis, infection, seroma, hematoma, is compared between the two groups.","Within 30 days post-surgery and at long-term follow-up assessments",{"measure":46,"description":47,"timeFrame":34},"Cost-Utility Analysis","A cost-utility analysis will be performed to compare the two groups. The incremental cost-utility ratio (ICUR) will be calculated to evaluate the cost-utility of the two surgical strategies.",{"measure":49,"description":50,"timeFrame":51},"Operative Time","Operative time (minutes) is compared between the two groups.","During surgery, recorded in the operative note",{"measure":53,"description":54,"timeFrame":51},"Axillary operation","Record the axillary surgical procedure of the two groups (None\u002FSentinel lymph node dissection\u002FAxillary lymph node dissection)",{"measure":56,"description":57,"timeFrame":51},"Intraoperative Blood Loss","Intraoperative Blood Loss(mL) is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups.",{"measure":59,"description":60,"timeFrame":61},"Postoperative Recovery Parameters","Length of postoperative hospital stay (days) and duration of postoperative drainage (days) are compared between the robotic-assisted and endoscopic-assisted groups.","During index hospitalization and within 30 days post-surgery",{"allocation":63,"interventionModel":64,"interventionModelDescription":15,"primaryPurpose":65,"observationalModel":15,"timePerspective":15,"maskingInfo":66},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":67,"maskingDescription":15,"whoMasked":15},"NONE",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"Robotic-assisted nipple-sparing mastectomy group","EXPERIMENTAL","Patients undergo robotic-assisted nipple-sparing mastectomy for breast cancer.",[74],"Procedure: Robotic-assisted nipple-sparing mastectomy",{"label":76,"type":71,"description":77,"interventionNames":78},"Endoscopic-assisted nipple-sparing subcutaneous mastectomy group","Patients undergo endoscopic-assisted nipple-sparing mastectomy for breast cancer.",[79],"Procedure: Endoscopic-assisted nipple-sparing mastectomy",[81,86],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":15},"PROCEDURE","Robotic-assisted nipple-sparing mastectomy","Robotic-assisted nipple-sparing mastectomy for breast cancer.",[70],{"type":82,"name":87,"description":88,"armGroupLabels":89,"otherNames":15},"Endoscopic-assisted nipple-sparing mastectomy","Endoscopic-assisted nipple-sparing mastectomy for breast cancer.",[76],[91],{"name":92,"role":93,"phone":94,"phoneExt":15,"email":95},"Haiyan Li","CONTACT","+8615813340604","lihaiyan@gwcmc.org",[97],{"facility":98,"status":15,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Guangzhou Women and Children's Medical Center, Guangzhou Medical University","Guangzhou","Guangdong","510000","China","CN",{"type":105,"coordinates":106},"Point",[107,108],113.25,23.11667,{"lat":108,"lon":107},[111],{"name":92,"role":93,"phone":94,"phoneExt":15,"email":95},{"type":113,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":15,"oldOrganization":15},"PRINCIPAL_INVESTIGATOR","haiyanli","Chief Physician, Department of Breast Surgery","100658229","impact-of-robotic-versus-endoscopic-surgery-on-nipple-nerve-function-following-nipple-sparing-mastectomy-for-breast-cancer-100658229",false,"NCT07850154","Impact of Robotic Versus Endoscopic Surgery on Nipple Nerve Function Following Nipple-Sparing Mastectomy for Breast Cancer","A Multicenter, Prospective, Randomized Two-arm Controlled Trial Comparing the Impact of Robotic Versus Endoscopic Surgery on Breast Nerve Function Following Nipple-sparing Mastectomy for Breast Cancer","Inclusion Criteria:\n\n1. Ductal carcinoma in situ (DCIS), or invasive breast cancer with clinical stage T1-T3, N0-N1 and no distant metastasis;\n2. Breast size ≤ cup C, without significant breast ptosis;\n3. Patients with high aesthetic requirements who elect single-incision robotic or endoscopic-assisted nipple-sparing mastectomy;\n4. Patients eligible for prophylactic mastectomy;\n5. Patients understand the study protocol and sign the written informed consent form.\n\nExclusion Criteria:\n\n1. Tumor invasion of the nipple-areola complex, skin, or chest wall;\n2. Inflammatory breast cancer;\n3. Patients with poor general condition who are unable to tolerate surgery.","ALL",{"count":125,"type":126},374,"ESTIMATED","INTERVENTIONAL",[129],"NA","This is a multicenter, prospective, randomized parallel controlled two arm clinical trial, designed to systematically evaluate impact of robotic versus endoscopic surgery on breast nerve function in patients undergoing nipple sparing mastectomy for breast cancer. The study will comprehensively assess the neurological functional outcomes, oncological safety, quality of life and sexual health, perioperative efficacy, surgical complications, and health economic value of the two minimally invasive approaches.\n\nThis study has been approved by the Institutional Review Board of the Affiliated Women and Children's Medical Center of Guangzhou Medical University. Written informed consent will be obtained from all eligible participants prior to enrollment. All patient data will be anonymized and kept strictly confidential. Statistical analyses will be performed using SPSS 27.0 software, with a P value \\\u003C 0.05 set as the threshold for statistical significance.",[132],"Breast Neoplasms",[134,135,136,137,138,139,140,141],"Breast cancer","Nipple-sparing mastectomy","Robot-assisted surgery","Endoscopic surgery","Sensation","Erection","Quality of Life","Sexual well-being","NOT_YET_RECRUITING","2026-09-29",{"date":145,"type":146},"2026-09-30","ACTUAL",{"date":148,"type":126},"2026-10-01",{"date":150,"type":126},"2031-10-01",{"name":5,"class":6},1]