Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Secondary Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- rate of postoperative early complications
研究概览
简要总结
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.
详细描述
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old,
- •Signed consent to participate,
- •Women with breast cancer over 18 or at high risk of breast cancer (BRCA 1-2 mutations, PALB2, extensive border lesions)
- •Mastectomy with conservation of the areolo-mammary plaque, or mastectomy without conservation of the areolo-mammary plaque and conservation of the skin case
- •Mastectomy without conservation of the areolo-mammary plate, immediate breast reconstruction by prosthesis,
- •immediate breast reconstruction by autologous latissimus dorsi flap
- •immediate breast reconstruction by latissimus dorsi flap and prosthesis,
- •secondary breast reconstruction by latissimus dorsi flap
- •Affiliation to, or beneficiary of, a social security scheme.
排除标准
- •Patient under 18,
- •Pregnant woman or likely to be (without effective contraception) or breastfeeding,
- •Person in emergency situation, adult person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or out of state to express his consent,
- •Inability to submit to medical follow-up for the trial for geographic, social or psychological reasons.
结局指标
主要结局
rate of postoperative early complications
时间窗: 90 days
To assess the value of robotic surgery for breast mastectomy with preservation of the nipple-areola complex and immediate or delayed reconstruction by latissimus dorsi flap, with an evaluation of the rate of postoperative early complications (90 postoperative days)
次要结局
未报告次要终点