Randomized Clinical Trial of Axillary Lymphadenectomy Without Drainage for Breast Cancer Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Safety
研究概览
简要总结
To study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy.
详细描述
The primary objective is to study the safety of not draining the axilla, considering the total number of patients without complication among breast cancer patients treated by means of conservative surgery and full axillary lymphadenectomy, with or without axillary drainage.
The secondary objectives will be the numbers of aspiration punctures, volumes of fluid aspirated and the total volumes of fluid produced.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage I and II breast cancer patients
- •Will be submitted to breast conserving therapy, with full axillary lymphadenectomy
排除标准
- 未提供
结局指标
主要结局
Safety
时间窗: 6 months
The safety of not draining the axilla, will be considered by the total number of patients without complication among breast cancer patients treated by means of breast conserving surgery and full axillary lymphadenectomy
次要结局
- Serous fluid(6 months)