Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction

NARecruitingINTERVENTIONAL
Enrollment

790

Participants

Timeline

Start Date

October 26, 2022

Primary Completion Date

June 30, 2032

Study Completion Date

June 30, 2032

Conditions
Breast Cancer Classified as TNM Stage 0-IIIa
Interventions
PROCEDURE

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."

PROCEDURE

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."

Trial Locations (14)

Unknown

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

All Listed Sponsors
lead

Yonsei University

OTHER