Lymphedema in the Lower Extremities After Urologic Surgery With Lymph Node Dissection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Number of patients with self-reported lymphedema at 12 months
研究概览
简要总结
Lymphedema of the extremities is common after lymph node surgery in treating several forms of cancer, e.g., breast cancer. However, very little is known of the occurrence of lymphedema of the lower extremities after urologic surgery with lymph node dissection. This project aims to describe the frequency and grade of lymphedema arising after urologic surgery, using the Lymphedema Quality of Life Questionnaire (LymQOL), Delfin MoistureMeter D, and lower limb volume measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients undergoing urologic surgery with lymph node dissection
排除标准
- 未提供
结局指标
主要结局
Number of patients with self-reported lymphedema at 12 months
时间窗: 12 months after surgery
Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire
Number of patients with self-reported lymphedema at 24 months
时间窗: 24 months after surgery
Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire
Change in tissue water content measured by MoistureMeterD Compact at 12 months
时间窗: 12 months after surgery
Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact
Change in tissue water content measured by MoistureMeterD Compact at 24 months
时间窗: 24 months after surgery
Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 12 months
时间窗: 12 months after surgery
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 24 months
时间窗: 24 months after surgery
次要结局
- Number of patients with self-reported lymphedema at 3 months(3 months after surgery)
- Number of patients with self-reported lymphedema at 1 month(1 month after surgery)
- Change in tissue water content measured by MoistureMeterD Compact at 3 months(3 months after surgery)
- Change in lower limb volume calculated by measuring the circumference of the lower extremities at 1 month(1 month after surgery)
- Number of patients with self-reported lymphedema at 6 months(6 months after surgery)
- Change in tissue water content measured by MoistureMeterD Compact at 1 month(1 month after surgery)
- Change in tissue water content measured by MoistureMeterD Compact at 6 months(6 months after surgery)
- Change in lower limb volume calculated by measuring the circumference of the lower extremities at 3 month(3 month after surgery)
- Change in lower limb volume calculated by measuring the circumference of the lower extremities at 6 month(6 month after surgery)