NCT01286337已完成3 期
Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- reduction of lymphorrhea rate
研究概览
简要总结
lymphorrehea remains the most frequent complication after axillary lymphadenectomy. we hyphothesize that the use of a bipolar vessel sealing may reduce the rate of lymph collection compared to the traditional surgical technique
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with documented breast cancer (by histology or cytology) and candidate to elective axillary lymphadenectomy
排除标准
- •Age less than 18 years
- •Denied written informed content
- •Previous axillary operations (except for sentinel node biopsy)
- •Preoperative radio-chemotherapy
- •Scheduled reconstructive breast operation
研究组 & 干预措施
vessel sealing
Experimental
axilla dissection using this device
干预措施: bipolar vessel sealing (Procedure)
control
Active Comparator
standard surgical technique
干预措施: control (Procedure)
结局指标
主要结局
reduction of lymphorrhea rate
时间窗: forth postoperative day
次要结局
- reduction of lymph output from the axillary drain(forth postoperative days)
研究者
研究点 (1)
Loading locations...
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