Lymfo-Veneuse Anastomosen Ter Preventie Van Lymphoedeem
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The volume via circumferential measurements: swelling < 5%
研究概览
简要总结
Lymphedema is defined as a chronic condition, caused by lymphostasis. A major part in the Western world consists of iatrogenic lymphedema caused by surgery to the lymph nodes of the axilla or groin. Prophylactic lymphovenous anastomosis (LVA) could be beneficial in the prevention of lymphedema of the extremities.
详细描述
The investigator is performing a blinded randomized prospective study on 80 patients undergoing an axilla dissection for their breast cancer treatment. One group will receive a LVA at the time of their axilla dissection. Other group will receive standard of care. Follow-up is 2 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •lymph node + breast cancer requiring dissection
排除标准
- •previous lymphedema
结局指标
主要结局
The volume via circumferential measurements: swelling < 5%
时间窗: 2 years
Comparing the volume of the arm at each study visit via circumferential measurements: swelling \< 5%
次要结局
未报告次要终点