Prospective Randomised Clinical Trial Comparing the Effect of Early and Late Drainage Removal in Female Patients After Radical Mastectomy With Axillary Clearance
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total lymph volume and time
研究概览
简要总结
The aim of the study is to assess whether early drainage removal in patients with less than 150ml of lymph in postoperative day 1 can reduce total lymphorrhoea
详细描述
Patients with early drainage removal will be compared with patients in whom drainage will be kept until daily lymphorrhoea is 30ml
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage IIA and IIB breast cancer treated with radical mastectomy
- •Obtaining informed consent
- •Total amount of lymph in postoperative day 1 <150ml
排除标准
- •Stage I, III-IV breast cancer
- •History of benign breast neoplasm or malignant disease of any origin
- •Any breast surgery in the past
- •Weight <50kg
研究组 & 干预措施
Early drainage removal
Patients randomised to early drainage removal arm will have the drain removed in postoperative day 1. Lymph will be punctured on a regular basis
干预措施: Early drainage removal (Procedure)
Late drainage removal
Patients randomised to late drainage removal arm will have the drains kept until total daily drainage is 30ml and then removed
干预措施: Late drainage removal (Procedure)
结局指标
主要结局
Total lymph volume and time
时间窗: 3 months
Assessment of total lymph volume and lymphorrhoea time up to 3 months after the surgery
次要结局
- Post operative pain assessment(30 days)
研究者
Jacek Zielinski
Assistant Profesor
Medical University of Gdansk