Axillary Versus Primary Breast Approach for Second-stage Operation in Expander-Implant Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Proportion of Wound healing within 7 days post-operation
研究概览
简要总结
The goal of this clinical trial is to compare the safety of axillary or primary breast approach for second-stage operation in expander-implant breast reconstruction for breast cancer patients. The main question it aims to answer are: 1. if the wound related events, including wound dehiscence, infection, delayed healing is significant less often in patients receiving second stage operation via axillary approach compared with primary breast approach; 2. if the aesthetic outcome is comparable between patients receiving different approach for second stage operation. To answer these questions, the breast cancer patients have received nipple-sparing or skin-sparing mastectomy and had breast tissue expander insertion via breast incision, will be prospectively recruited, and randomized into two groups while receiving implant exchange operation: (1) operate via axillary incision; (2) operate via primary breast incision.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 + (inclusive)
- •Invasive breast cancer or ductal carcinoma in situ was confirmed by preoperative pathology
- •SSM/NSM (skin sparing/nipple and areola sparing mastectomy) combined with expander implantation has been performed within a year
- •An incision on the surface of the breast is used to place an expander in the first-stage surgery
- •There is no clinical or radiological evidence of distant metastasis
- •Expander removal combined with prosthesis implantation is planned
- •Able and willing to sign an informed consent
排除标准
- •The first SSM/NSM combined expander implantation was performed via axillary approach
- •Patients participate in other clinical trial, which could potentially affect their participation in this trial
- •Adjuvant radiotherapy was planned post-operation
- •Patient who is pregnant and lactating
- •The expander is not sufficiently expanded pre-surgery (does not reach more than 90% of its volume)
结局指标
主要结局
Proportion of Wound healing within 7 days post-operation
时间窗: up to 7 days post-operation
Without one of the following conditions：wound dehiscence requiring local wound care or operative intervention, wound infection requiring antibiotics 24hours post-operation, or debridement, within 7 days of post-operation.
次要结局
- Length of incision(up to 7 days post-operation)
- other surgical complications(one year)
- Breast Q score(one year)
- Pathological evaluation(through study completion)