Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Presence of tumor in nipple areolar complex frozen section
研究概览
简要总结
The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex.
详细描述
The outcomes will be observed in patients with both known cancer diagnosis and in those with indications for prophylactic mastectomy. The cosmetic appearance and complications will be followed through several post operative visits throughout the duration of the study. This study is conducted in conjunction with the plastic and reconstructive surgeons who will be performing the breast reconstruction procedures. Patient satisfaction will be measured via survey format. In addition, local recurrence rates will be compared to patients undergoing traditional mastectomy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients requiring mastectomy for cancer and/or prophylaxis
- •Age greater than or equal to 18 at time of surgery
- •BMI less than or equal to 35
- •If mastectomy is indicated for removal of breast cancer, tumor is clinically T1 or T2
排除标准
- •Currently smoking
- •Prior radiation to the affected breast
- •Systemic lupus erythematosus
- •Central tumor location and/or tumor within 2 cm of NAC
- •Paget's disease of the nipple
- •Clinical evidence of tumor involvement in the nipple
- •Clinical evidence of axillary nodal tumor involvement
- •Lymphovascular invasion of the tumor on core biopsy
结局指标
主要结局
Presence of tumor in nipple areolar complex frozen section
时间窗: Duration of Study
Presence of tumor in nipple areolar complex permanent histology
时间窗: Duration of study
Cosmetic Appearance
时间窗: First Post Operative year
Patient Satisfaction
时间窗: First Post Operative Year
次要结局
- Complications(First Post Operative year)
- Local Recurrence(One year)