Prospective Clinical Study of Single Port Endoscopic Breast Conserving Surgery or Open Breast Conserving Surgery for Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Six months after operation SURVIVAL EFFECTS
研究概览
简要总结
The center plans to carry out a prospective clinical study of single hole total endoscopic breast conserving surgery for early breast cancer compared with open breast conserving surgery, to provide high-level evidence-based medical evidence for the development of endoscopic breast conserving surgery for early breast cancer.
详细描述
Data show that breast cancer has surpassed lung cancer asthemost prevalent malignant tumor in the world, and traditional open surgery is highly invasive and has poor cosmetic results. This study investigates the results of endoscopic breast- conserving surgery(E-BCS) versus conventional breast-conserving surgery(C-BCS) in the treatment of patients with early-stage breast cancer and to compare the advantages and disadvantages of the two surgical procedures, so as to provide the best evidence for the rational choice of the procedure by both doctors and patients.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer confirmed by pathology；
- •Tumor <5 cm, TNM stage 0-II；
- •Single Port Endoscopic or traditional open surgery; (4)20 to 70 years old female patients.
排除标准
- •Bilateral breast cancer;
- •Reconstruction after breast conserving surgery ;
- •Basic information is not complete；
- •Breast conserving surgery was converted to modified radical resection or subcutaneous adenoidectomy.
结局指标
主要结局
Six months after operation SURVIVAL EFFECTS
时间窗: From enrollment to the end of 6 months after surgery
To compare the overall survival (OS) within 6 months after single-port endoscopic breast-conserving surgery and open breast-conserving surgery.
次要结局
- Intraoperative blood loss(From the beginning to the end of the operation)
- Postoperative drainage volume in the first three days after breast conserving surgery(3 days after surgery)
- Length of surgical incision(1 week after surgery)
研究者
Ren,Yu
chief physician
First Affiliated Hospital Xi'an Jiaotong University