An observational study in Postoperative Complications, Recurrence and Breast Neoplasms, sponsored by Severance Hospital. Completed at 1 site in Korea, Republic of. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Severance Hospital · Observational
Robotic mastectomy with immediate reconstruction was introduced by Toesca et al. in 2015. Since then, several studies have reported the safety and feasibility of robotic nipple-sparing mastectomy with immediate reconstruction. However, most studies were conducted by single centers and had 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 with immediate reconstruction using international multi-center data.
This study is an international multi-center pooled analysis using prospective and retrospective studies to evaluate surgical and oncologic outcomes of robotic nipple-sparing mastectomy with immediate reconstruction.
Raw data for robotic or conventional nipple-sparing mastectomy from Severance Hospital, Samsung Medical Center, the European Institute of Oncology, Changhua Christian Hospital, and Gustave Roussy is collected. Among them, Severance Hospital takes the lead at performing analysis from the data. Storage and disposal of patients' records are managed by each researcher. In the analysis process, although the collaborators can request records from Severance Hospital if necessary, they are only supposed to be provided computerized data which were originally clinical data from patients who already ended treatments. In this case, individual identifying data and medical records are not shown.
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 within 30 days are collected and classified by the Clavien-Dindo grade. Locoregional recurrence-free survival and local and systemic recurrences are examined. Patients whose data have been retrospective for at least one month are to be 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.
Propensity matching analysis is applied to reduce confounding factors.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's enrollment of 659 is above the median of 251 across 537 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Severance Hospital is the lead sponsor of 51 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who underwent nipple-sparing mastectomy between 2016 and 2020 at Severance Hospital, Seoul, Korea.
Patients who underwent nipple-sparing mastectomy between 2016 and 2020 at Samsung Medical Center, Seoul, Korea.
Patients who underwent nipple sparing mastectomy between 2014 and 2019 at European Institute of Oncology, Milan, Italy.
Patients who underwent nipple-sparing mastectomy between 2017 and 2019 at Changhua Christian Hospital, Changhua City, Taiwan.
Patients who underwent nipple-sparing mastectomy between 2015 and 2019 at Gustave Roussy, Paris, France.
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Exclusion Criteria:
Cases or Patients who underwent robotic nipple-sparing mastectomy and immediate reconstruction are enrolled in this arm. Robotic nipple-sparing mastectomy should be performed using robotic surgical systems. Robotic surgical systems include da Vinci S,Si, X, Xi, and SP systems. Axillary or lateral incisions are used for this procedure. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases with robotic mastectomy without immediate reconstruction are excluded. The estimated sample size for this arm is 300 cases.
Procedure: Robotic nipple sparing mastectomy
Cases or Patients who underwent conventional nipple-sparing mastectomy and immediate reconstruction are enrolled in this arm. Conventional nipple-sparing mastectomy should not be performed using robotic or endoscopic surgical systems. Axillary or lateral incisions that are similar to incisions in robotic nipple-sparing mastectomy are not allowed. Other than axillary or lateral incisions can be performed for this procedure. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases with nipple-sparing mastectomy without immediate reconstruction are excluded. The estimated sample size for this arm is 300 cases.
Robotic nipple sparing mastectomy means nipple sparing mastectomy performed using robotic surgical systems.
Also known as: Robot-assisted nipple sparing mastectomy, Robot mastectomy, Robotic mastectomy, Hybrid robotic nipple sparing mastectomy, Robot-assisted nipple areolar complex and skin sparing mastectomy
Postoperative complication rates in 30 days
Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.
Time frame: Postoperative 30 days
Clavien-Dindo grade of postoperative complications
Clavien-Dindo grade of postoperative complications is evaluated. The highest grade of postoperative complications are used for the analysis.
Time frame: Postoperative 30 days
Nipple necrosis rates
Nipple necrosis rates are calculated as number of total nipple necrosis cases per total operation cases.
Time frame: Postoperative 30 days
Recurrence free survival (RFS)
Events of RFS includes locoregional recurrence, distant recurrence, and death. Contralateral breast cancer and second primary malignancy are considered to be censored data.
Time frame: Postoperative 5 years
Operation times
Mastectomy time or reconstruction time
Time frame: Time during operation
Locoregional recurrence-free survival (LRFS)
In breast tumor recurrences (IBTR), regional recurrences including axillary, internal mammary, or supraclavicular lymph node recurrences, and death without any cause are events of locoregional recurrence-free survival. Five year LRFS is measured. Distant metastasis, contralateral breast cancer and second primary malignancy are considered to be censored data.
Time frame: Postoperative 5 years
Plan to share: Undecided — After completion of this study, IPD can be considered based on the decision of the study steering comittee.
Ran from May 2020 to primary completion in May 2022, 23 months.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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