Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Robotic NSM
* Procedure: Open NSM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invasive breast cancer, Ductal Carcinoma In Situ, Breast Related Cancer Antigens mutation carriers. Any age Candidates to nipple-sparing mastectomy and immediate breast reconstruction Negative preoperative assessment of nipple-areola complex Absence of skin involvement Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section Breast volume ≤ Bra IV; from cup A to D No hard smoking (hard smoking defined as >20 cigarettes/day) Low and intermediate risk for anesthesia (ASA Scale) Written informed consent must be signed and dated by the patient and the investigator prior to inclusion Patients must be accessible for follow-up Exclusion criteria: Previous thoracic radiation therapy for any reason Inflammatory Breast Cancer Skin involvement Pre-operative diagnosis (radiological or cytological) of nipple-areola complex disease Pregnancy Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study Uncompensated Diabetes Mellitus Hard smokers (hard smoking defined as >20 cigarettes/day) High risk for anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open NSM<br>Conventional Nipple Sparing Mastectomy | Procedure: Open NSM<br>* Open nipple-sparing mastectomy and immediate breast reconstruction with implant<br>|
| Experimental: Robotic NSM<br>Robotic Nipple-Sparing Mastectomy | Procedure: Robotic NSM<br>* Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | The BREAST-Q survey is used to detect differences in patient satisfaction among the groups | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average length of stay of patients | Reduction of the average length of stay of patients of the two different surgical techniques. | 1 month | 
| Post operative complications | Compare post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma) | 1 month | 
| Cumulative incidence of local recurrence | Cumulative incidence of local recurrence | 5 years | 
| Cumulative incidence of axillary recurrences | Cumulative incidence of axillary recurrences | 5 years | 
| Cumulative incidence of distant recurrences | Cumulative incidence of distant recurrences | 5 years | 
| Disease free survival | Disease free survival | 5 years | 
| Overall survival | Overall survival | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic Mastectomy, Nipple Sparing Mastectomy, Conservative mastectomy, Breast reconstruction