protocolSection identificationModule nctId: NCT06335550, orgStudyIdInfo id: 2021/2680, briefTitle: Surgical and Patient Reported Outcomes in Robotic Mastectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-24, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Changi General Hospital, class: OTHER, descriptionModule briefSummary: Conventional nipple and/or skin-sparing mastectomy (NSM/SSM) with or without immediate reconstruction is becoming one of the mainstream surgical treatment for breast cancer and risk reducing mastectomy in recent years. While this technique provides satisfactory oncologic and aesthetic outcomes, its disadvantages include skin flap and/or nipple-areolar complex (NAC) necrosis, NAC malposition/distortion as well as visible scar(s) on the breast.In terms of technical aspects, NSM/SSM has its inherent challenges in view of limited incisions and thereby difficulties in dissection. Since 2015, a number of institutions worldwide had adopted a new technique of NSM/SSM using robotic surgical system. Institutional experiences worldwide demonstrated feasibility and safety of this technique coupled with improved patients' satisfactions.To date, there is no center in Singapore or the region offering Robotic NSM/SSM (R-NSM/R-SSM). The authors believe that robotic mastectomy is a feasible and safe technique that can be utilized in our institution and it provides superior aesthetic outcomes with less morbidity and higher patient satisfaction if compared to conventional NSM/SSM.The aim of this study is to conduct a single-arm prospective pilot study to investigate the safety and feasibility as well as learning curve of R-NSM/R-SSM., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 29, type: ACTUAL, armsInterventionsModule interventions name: Robotic mastectomy, outcomesModule primaryOutcomes measure: Surgical Outcomes - Operative parameters, primaryOutcomes measure: Surgical Outcomes - Length of stay (days), primaryOutcomes measure: Surgical Outcomes- 30-days morbidity/complications, secondaryOutcomes measure: Oncologic outcomes, secondaryOutcomes measure: Learning curve, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changi General Hospital, city: Singapore, zip: 529889, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-07-05, uploadDate: 2024-03-08T05:13, filename: Prot_SAP_000.pdf, size: 785756, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-05-03, uploadDate: 2024-03-08T05:19, filename: ICF_001.pdf, size: 704077, hasResults: False