NCT02673268Unknown2 期
Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Rate of necrosis
研究概览
简要总结
The objective of this study is to demonstrate the feasibility of a mastectomy with conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate breast reconstruction using prosthesis.
The interest is to avoid scars on the breast. The scars are limited to the armpit and under the arm.
The aim is also to study the rate of complications, cosmetic results and quality of life.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1 .Patients with an indication of mastectomy with areola conservation
- •In case of carcinologic surgery:
- •Disease located more than 2cm of the areola on the clinical and paraclinical evaluation
- •Patients with indication of total mastectomy
- •Patients looking for immediate reconstruction
- •In case of prophylactic surgery
- •Patients wishing a prophylactic surgery because of highly risked mutation (BRCA1, BRCA2....)
- •Cup A, B or C maximum
- •Aged between 18 and 70 years old
- •Signed informed consent
- •Patients affiliated to a social security system
排除标准
- •Patients with a high risk of skin necrosis
- •Planned post operative radiotherapy
- •Patients with an historic of breast surgery on the side that needs to be operated
- •Pregnant or breastfeeding women
- •Persons deprived of liberty
- •Persons not able to undergo medical follow up due to geographical, social or psychic reasons
研究组 & 干预措施
Patients with breast cancer
Experimental
干预措施: Mastectomy (Procedure)
Patients with breast cancer
Experimental
干预措施: Da Vinci Robot Xi (Device)
结局指标
主要结局
Rate of necrosis
时间窗: Assessed up to 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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