Randomized Controlled Trial of Safety and Aesthetic Outcomes of Breast-conserving Surgery With the Peri-areolar Incision Approach
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- event free survival
研究概览
简要总结
Cosmetic result after breast-conserving surgery (BCS) would impose great effect upon patient's quality of life. Although peri-areolar incision has been widely used in benign breast tumor excision, mastopexy procedures and skin-sparing mastectomy with primary reconstruction, the actual safety and aesthetic outcome of the peri-areolar incision approach in BCS for cancer patients has not been established by randomized, controlled trials.
This trial was design to compare the Safety and aesthetic outcomes of breast conserving surgery between peri-areolar incision approach and traditional methods.
详细描述
The Trial aims to determine whether BCS with the peri-areolar approach: 1) is safe in terms of the rates of recurrence and metastasis; 2) can improve the post-operative aesthetic score and QOL score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients desire for breast conserving surgery;
- •fulfills criteria for breast conserving surgery;
- •the maximum diameter of the tumor should be less than the semi-perimeter of the areola and that the proximal margin of tumor should be at least 1 cm away from the areola;
- •patients suitable to receive BCS with either the peri-areolar incision or the traditional incision were included;
排除标准
- •patients not suitable for breast conserving surgery;
- •skin or sub-cutaneous tumor invasion as definite contra-indication of skin-sparing;
- •male or bilateral breast cancers who might bring up bias in deciding aesthetic outcomes and expenditure;
- •Patients who were supposed to benefit from a certain kind of incision were also excluded at the researcher's discretion.
研究组 & 干预措施
traditional incision
traditional incision above tumor was used to carry out lumpectomy
干预措施: traditional incision (Procedure)
peri-areolar incision
Peri-areolar incision was used to carry out lumpectomy
干预措施: peri-areolar incision (Procedure)
结局指标
主要结局
event free survival
时间窗: 5 years
local recurrence, regional recurrence, distant metastasis, death
次要结局
- cost(2 weeks)
- aesthetic outcomes(two weeks, half a year and one year)