NCT03104153已完成不适用
Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection on Clinical Outcome and Quality of Life in Breast Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 主要终点
- Quality of Life
研究概览
简要总结
To compare early drain removal versus output-based drain removal, assessing the following end-points:
Clinical : risk of seroma and infection, woundhealing, duration of wound care and drain output versus volume of seroma.
Quality of life : drain-induced pain, discomfort due to seroma or drain, sleep disturbance and implications on daily activities.
Cost-effectiveness
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for breast cancer surgery with placement of suction drainage
- •Female or male
- •Age > 18 years
- •All stages of disease (inclusion is independent of TNM-classification)
排除标准
- •Patients scheduled for breast cancer surgery without placement of suction drains
- •No informed consent: Patient refuses participation OR is not able to give a written informed consent
结局指标
主要结局
Quality of Life
时间窗: 3 weeks
Improve the quality of life, wich will be measured by a questionnaire with some specific questions.
次要结局
未报告次要终点
研究者
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