Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- patients complications after nipple sparing mastectomy
研究概览
简要总结
Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is a form of mastectomy that achieves optimal disease control and facilitates reconstruction. The study aimed to assess the oncological safety and aesthetic outcomes of nipple-sparing mastectomy and immediate breast reconstruction.
35 female patients with breast cancer were included in the study. The investigators categorized the incisions into radial, inframammary, and periareolar incisions with planned reconstruction types; direct to implant (DTI), transversus rectus abdominis myocutaneous (TRAM) flap, latissimus dorsi myocutaneous (LD) flap, or LD with implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 28 Years 至 68 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ductal in situ carcinoma or infiltrating ductal carcinoma with a tumor diameter up to 3 cm
- •Distance of the tumor from the nipple ≥ 2 cm
- •Cancer or microcalcifications not localized in the central field.
- •No blood secretions or other (nipple-areola complex) NAC disturbances
- •Absence of skin involvement
- •Indication to mastectomy for multifocal or diffuse microcalcifications
- •Negative intraoperative assessment of NAC-bottom
排除标准
- •Tumor or microcalcifications localized in the central quadrant or in the retroareolar region
- •Blood secretions or other NAC alterations
- •Positive intraoperative assessment of NAC-bottom
- •Inflammatory carcinoma
- •Paget's disease of the nipple
结局指标
主要结局
patients complications after nipple sparing mastectomy
时间窗: 2017-2019
Complete general examination, local examination of the skin, nipple and areola were done to determine whether the patients suffered from any complaints
次要结局
- Aesthetic results assessed by Tzafetta et al scoring system(2017-2019)