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Robotic mastectomy and immediate reconstruction have been introduced by Toesca et al. in 2015. Since then, several studies reported the safety and feasibility of robotic nipple-sparing mastectomy and immediate reconstruction. However, most studies were conducted by single centers and enrolled in small samples. Furthermore, there is a lack of studies comparing surgical and oncologic outcomes between robotic nipple-sparing mastectomy and conventional nipple-sparing mastectomy. For this reason, this study evaluates surgical and oncologic outcomes of robotic nipple-sparing mastectomy and immediate reconstruction using international multicenter data.
This study is an international multicenter pooled analysis using prospective or retrospective studies to evaluate surgical and oncologic outcomes of robotic nipple-sparing mastectomy and immediate reconstruction.
Raw data for robotic or conventional nipple-sparing mastectomy from Severance Hospital, European Institute of Oncology, Changhua Christian Hospital, and Gustave Roussy is collected.
Clinicopathologic variables including operation times, hospital stay, medical history, smoking history, family history, BMI, menopausal status, specimen weight, TNM stage, grade, histological type, estrogen receptor, progesterone receptor, HER2, Ki 67, and perivascular involvement are analyzed. Postoperative complications in 30 days are collected and classified by the Clavien-Dindo grade. Survival outcomes including 5-year locoregional recurrence-free survival, recurrence-free survival, and overall survival are examined. Patient's and surgeon's satisfaction using Breast Q is evaluated.
Categorical variables are examined using the chi-square test or Fisher's exact test if indicated.
Continuous variables are examined using the independent t-test or ANOVA if indicated.
The estimated sample size from the four institutions is about 300 cases for robotic nipple-sparing mastectomy and matched cases for conventional nipple-sparing mastectomy.
Robotic nipple sparing mastectomy
Yonsei University College of Medicine
Korea, Republic of
Not yet recruiting
Published on BioPortfolio: 2019-10-03T07:54:42-0400
This study will retrospectively collect and evaluate the surgical outcomes of robotic nipple sparing mastectomy (R-NSM) compared with endoscopic assisted NSM (E-NSM) or conventional NSM (C...
This study will prospectively evaluate the surgical outcomes of robotic nipple sparing mastectomy (NSM) compared with endoscopic assisted NSM or conventional NSM in the management of breas...
Prospective collection of health related personal data and biological material (tissue biopsy) in patients undergoing mastectomy.
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Removal of only the breast tissue and nipple and a small portion of the overlying skin.
Excision of breast tissue with preservation of overlying skin, nipple, and areola so that breast form may be reconstructed.
Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery.
Total mastectomy with axillary node dissection, but with preservation of the pectoral muscles.
Fluid collected from nipple by gentle aspiration. The fluid contains cells and extracellular fluid from the breast ductal epithelium.
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...
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