Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction

Robotic NSM

Open nipple-sparing mastectomy and immediate breast reconstruction with implant

Open NSM

Antonio Toesca, MD

This trial is designed to compare robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with conventional open technique. It is a prospective randomized trial evaluating patients satisfaction

High proportion of patients with newly diagnosed early-stage breast cancer in Europe and US undergo to mastectomy. The absolute numbers of mastectomy rates in US is still today around 38% and represent one of the most performed operation for cancer reasons. Despite the lack of a natural cavity needed for endoscopic viewing, applications of robotic surgery have recently emerged for superficial organs such as in the fields of thyroidectomy, oropharyngeal surgery, plastic and reconstructive surgery. However, it has never been applied in breast cancer except for a feasibility and safety study conducted at European Institute of Oncology.

The technique was firstly published by Toesca et al. considering the first 3 cases. The same research as continued on breast cancer evaluating feasibility, reproducibility and safety studying 26 consecutive procedures of robotic nipple sparing mastectomy and immediate robotic breast reconstruction (article under peer to peer review at European Journal of Surgical Oncology, EJSO). In these initial cases of robotic nipple sparing mastectomy and immediate breast reconstruction authors found two main advantages such as the robotic optical vision and the minimal invasiveness. The two main limitations noticed in this initial experience were the duration of operating time and the additional costs related to the operation. The limitations of the applicability of robotic surgery to the breast, such as operating time and costs, might be offset by the advantages they observed such as better vision and minimally invasive approach with an anatomically more respectful mastectomy.

This project is a superiority trial comparing robotic nipple sparing mastectomy and immediate breast robotic reconstruction with conventional open technique.

The primary end-point is to evaluate patient satisfaction. Second end-point is to compare post-operative outcome considering complications, post-operative pain, reduction of the average length of stay of patients, long term oncological outcome of the two different surgical techniques.

Patients will be randomized into two treatment arms:

A. Open nipple-sparing mastectomy and immediate breast reconstruction with implant (Open NSM) B. Robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with implant (Robotic NSM) Both arms will undergo to the same pre-surgical staging, intra-operative axillary surgical staging, post-operative multidisciplinary evaluation and adjuvant treatments according to international and internal protocols.

Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique

Robotic Nipple-Sparing Mastectomy And Immediate Robotic Breast Reconstruction Vs Conventional Open Technique: A Prospective Randomized Trial Evaluating Patients Satisfaction

The BREAST-Q survey is used to detect differences in patient satisfaction among the groups

Reduction of the average length of stay of patients of the two different surgical techniques.

Compare post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma)

Cumulative incidence of axillary recurrences

Cumulative incidence of distant recurrences

European Institute of Oncology

Breast Diseases

Skin Diseases

All consecutive cases of robotic mastectomy over the study duration

Robotic mastectomy with or without reconstruction

Robotic mastectomy

Chi Wei Mok

Conventional nipple and/or skin-sparing mastectomy (NSM/SSM) with or without immediate reconstruction is becoming one of the mainstream surgical treatment for breast cancer and risk reducing mastectomy in recent years. While this technique provides satisfactory oncologic and aesthetic outcomes, its disadvantages include skin flap and/or nipple-areolar complex (NAC) necrosis, NAC malposition/distortion as well as visible scar(s) on the breast.

In terms of technical aspects, NSM/SSM has its inherent challenges in view of limited incisions and thereby difficulties in dissection. Since 2015, a number of institutions worldwide had adopted a new technique of NSM/SSM using robotic surgical system. Institutional experiences worldwide demonstrated feasibility and safety of this technique coupled with improved patients' satisfactions.

To date, there is no center in Singapore or the region offering Robotic NSM/SSM (R-NSM/R-SSM). The authors believe that robotic mastectomy is a feasible and safe technique that can be utilized in our institution and it provides superior aesthetic outcomes with less morbidity and higher patient satisfaction if compared to conventional NSM/SSM.

The aim of this study is to conduct a single-arm prospective pilot study to investigate the safety and feasibility as well as learning curve of R-NSM/R-SSM.

Surgical and Patient Reported Outcomes in Robotic Mastectomy

Pilot Robotic Mastectomy in Singapore (PRoMiSing I) Study: First Safety and Feasibility Prospective Cohort Study in South East Asia

- Operative parameters (in terms of docking time/console time and total operative time - defined as time taken from axilla staging procedure, robot docking time, console time, closure and time taken for reconstruction, if applicable

Short-term oncologic outcomes, such as positivity of margins

Learning curve analysis using cumulative sum (CUSUM) method

Changi General Hospital

Principal Investigator; Clinical Assistant Professor

Symptoms and General Pathology

Recurrence

Postoperative Complications

Disease Attributes

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.

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.

Robotic nipple sparing mastectomy

Hyung Seok Park, MD, PhD

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.

Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction

Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction : an International Multicenter Pooled Analysis

After completion of this study, IPD can be considered based on the decision of the study steering comittee.

Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.

Clavien-Dindo grade of postoperative complications is evaluated. The highest grade of postoperative complications are used for the analysis.

Nipple necrosis rates are calculated as number of total nipple necrosis cases per total operation cases.

Events of RFS includes locoregional recurrence, distant recurrence, and death. Contralateral breast cancer and second primary malignancy are considered to be censored data.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique	NCT03440398	Breast Cancer	Robotic NSM Open NSM	18 Years -	European Institute of Oncology
Surgical and Patient Reported Outcomes in Robotic Mastectomy	NCT06335550	Breast Cancer	Robotic mastect...	21 Years - 70 Years	Changi General Hospital
Surgical and Patient Reported Outcomes in Robotic Mastectomy	NCT06335550	Breast Cancer	Robotic mastect...	21 Years - 70 Years	Changi General Hospital
Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction	NCT04108117	Postoperative C... Recurrence Breast Neoplasm... Breast Cancer BRCA1 Mutation BRCA2 Mutation Surgery Surgery--Compli...	Robotic nipple ...	-	Severance Hospital
Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction	NCT04108117	Postoperative C... Recurrence Breast Neoplasm... Breast Cancer BRCA1 Mutation BRCA2 Mutation Surgery Surgery--Compli...	Robotic nipple ...	-	Severance Hospital

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