跳至主要内容
临床试验/NCT01286337
NCT01286337已完成3 期

Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique

University of Milano Bicocca2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
116
试验地点
2
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

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

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

申办方类型
Other

研究点 (2)

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