790
Participants
Start Date
October 26, 2022
Primary Completion Date
June 30, 2032
Study Completion Date
June 30, 2032
Robot-assisted Nipple-Sparing Mastectomy (RNSM)
"Patients undergoing robot-assisted nipple-sparing mastectomy (RNSM) with immediate breast reconstruction (IBR) will be enrolled in this group. RNSM will be performed using robotic surgical platforms, including the da Vinci S, Si, X, Xi, and SP systems. The procedure will be conducted through an axillary or lateral chest wall incision.~During surgery, posterior areolar tissue sampling for frozen section biopsy will be recommended. If suspicious lesions are detected at the superficial or posterior margins, frozen section biopsy of those lesions will also be performed. When tumor involvement of the nipple-areola complex (NAC), superficial margin, or posterior margin is confirmed by frozen section biopsy, additional resection including the skin and NAC, or postoperative radiotherapy, will be considered."
Conventional nipple sparing mastectomy(CNSM)
"Patients who undergo conventional nipple-sparing mastectomy (CNSM) with immediate breast reconstruction (IBR) will be enrolled in this group. CNSM is performed without the use of robotic or endoscopic surgical systems, and all types of skin incisions are permitted.~During surgery, posterior areolar tissue sampling for frozen section biopsy is recommended. If suspicious lesions suggesting tumor involvement are identified at the superficial or posterior margins, frozen section biopsy should also be performed. When frozen section biopsy confirms tumor involvement of the nipple-areola complex (NAC), superficial margin, or posterior margin, additional excision including the skin and NAC, or postoperative radiotherapy, will be considered."
NOT_YET_RECRUITING
Samsung Changwon Medical Center, Changwon
NOT_YET_RECRUITING
Keimyung University Dongsan Hospital, Daegu
NOT_YET_RECRUITING
Kyungpook National University Chilgok Hospital, Daegu
NOT_YET_RECRUITING
Myongji Hospital, Goyang-si
NOT_YET_RECRUITING
The Catholic University of Korea, Incheon ST. Mary's Hospital, Incheon
NOT_YET_RECRUITING
Kosin University Gospel Hospital, Pusan
NOT_YET_RECRUITING
Chungnam National University Sejong Hospital, Sejong
NOT_YET_RECRUITING
Asan Medical Center, Seoul
NOT_YET_RECRUITING
Gangnam Severance Hospital, Seoul
NOT_YET_RECRUITING
Korea University Anam Hospital, Seoul
NOT_YET_RECRUITING
Samsung Medical Center, Seoul
NOT_YET_RECRUITING
Seoul National University Hospital, Seoul
RECRUITING
Yonsei University Health System, Severance Hospital, Seoul
NOT_YET_RECRUITING
Yongin Severance Hospital, Yongin-si
Yonsei University
OTHER