Robotic Nipple-Sparing Mastectomy And Immediate Robotic Breast Reconstruction Vs Conventional Open Technique: A Prospective Randomized Trial Evaluating Patients Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Patient satisfaction
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Invasive breast cancer, Ductal Carcinoma In Situ, Breast Related Cancer Antigens mutation carriers.
- •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
排除标准
- •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
结局指标
主要结局
Patient satisfaction
时间窗: 1 year
The BREAST-Q survey is used to detect differences in patient satisfaction among the groups
次要结局
- Post operative complications(1 month)
- Cumulative incidence of local recurrence(5 years)
- Average length of stay of patients(1 month)
- Cumulative incidence of distant recurrences(5 years)
- Disease free survival(5 years)
- Cumulative incidence of axillary recurrences(5 years)
- Overall survival(5 years)