Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy for Breast Cancer

NAUnknownINTERVENTIONAL
Enrollment

900

Participants

Timeline

Start Date

August 22, 2019

Primary Completion Date

July 31, 2021

Study Completion Date

December 31, 2021

Conditions
Breast Cancer Female
Interventions
DEVICE

Robotic assisted nipple sparing mastectomy (R-NSM)

R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM, had been applied in the surgical treatment of early breast cancer or risk reducing mastectomy. R-NSM, which incorporated 3-dimensional (3D) imaging system and flexibility of robotic arm and instruments, was reported to have the potential to overcome the technique difficulty of E-NSM.

PROCEDURE

conventional nipple sparing mastectomy (C-NSM)

Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy, was increasingly performed in breast cancer patients due to better cosmetic outcome, higher patient satisfaction, and maintained oncologic safety.

PROCEDURE

Endoscopic assisted nipple sparing mastectomy (E-NSM)

E-NSM, which is performed through small axillary and/or peri-areolar incisions, was reported to be associated with small inconspicuous incision and good cosmetic outcome. Conventional E-NSM was performed with two separate incisions over axilla and peri-areolar regions. E-NSM with areolar incision, just like NSM with areolar related incision (NAC ischemia/necrosis rate: range 7%-81.8%), was associated with increased NAC ischemia/necrosis (reported ranged: 9.1-19%). New technique modifications of E-NSM were emerging focusing on single axillary incision NSM, which spare the peri-areolar incision and thereby decrease the compromise of bloody supply from mastectomy skin flap, was reported to have low NAC necrosis rate (0%).

Trial Locations (13)

Unknown

NOT_YET_RECRUITING

European Institute of Oncology, Milan

NOT_YET_RECRUITING

Severance Hospital, Seoul

RECRUITING

Changhua Christian Hospital, Changhua

RECRUITING

Kaohsiung Medical University Hospital, Kaohsiung City

RECRUITING

China Medical University Hospital, Taichung

NOT_YET_RECRUITING

National Cheng Kung University Hospital, Tainan City

NOT_YET_RECRUITING

National Taiwan University Hospital, Taipei

RECRUITING

Shin Kong Wu Ho-Su Memorial Hospital, Taipei

NOT_YET_RECRUITING

Taipei Municipal Wan Fang Hospital, Taipei

NOT_YET_RECRUITING

Taipei Veterans General Hospital, Taipei

RECRUITING

Tri-Service General Hospital, Taipei

RECRUITING

Shuang-Ho Hospital - Taipei Medical University, Taipei County

NOT_YET_RECRUITING

Chang Gung Memorial Hospital, Taoyuan District

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ministry of Science and Technology, Taiwan

OTHER_GOV

collaborator

Intuitive Surgical

INDUSTRY

lead

Changhua Christian Hospital

OTHER