Pilot Robotic Mastectomy in Singapore (PRoMiSing I) Study: First Safety and Feasibility Prospective Cohort Study in South East Asia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Surgical Outcomes - Operative parameters
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 21-70, with invasive breast cancer, ductal carcinoma in situ (DCIS), Breast Cancer (BRCA) gene or other breast cancer genetic mutation carriers or high risk female patients who are otherwise candidates for conventional NSM/SSM will be eligible for the study. All suitable patients will be offered the option of R-NSM/ R-SSM.
- •For patients with breast cancer (invasive or DCIS), selection criteria include but not limited to:
- •Early breast cancer
- •Tumor size less than 5 cm
- •No evidence of lymph node metastases
- •No evidence of skin or chest wall invasion.
排除标准
- •Extensive axillary lymph node metastasis (Stage 3B or later)
- •Heavy smokers (>20 cigarettes a day)
- •High risk patient with severe and poorly controlled co-morbid conditions (include but not limited to diabetes, heart disease, renal failure or liver dysfunction)
- •Poor performance status or high risk for anaesthesia (ASA 3 and above)
- •Inflammatory or Locally Advanced Breast Cancer (with or without chest wall or skin invasion)
结局指标
主要结局
Surgical Outcomes - Operative parameters
时间窗: Postoperative Day 0-1
\- 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
Surgical Outcomes - Length of stay (days)
时间窗: Postoperative 30 days
\- Length of stay (days)
Surgical Outcomes- 30-days morbidity/complications
时间窗: Postoperative 30 days
\- 30-days morbidity/complications
次要结局
- Learning curve(Postoperative up to 2 years throughout study recruitment)
- Oncologic outcomes(Postoperative 2 weeks until final histopathology results are available)
研究者
Mok Chi Wei
Principal Investigator; Clinical Assistant Professor
Changi General Hospital