NCT03248310招募中不适用
A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Quality of Life
研究概览
简要总结
This study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years
- •Primary and secondary lymphedema of the upper or lower extremity
- •International Society of Lymphology (ISL) Stage 1, 2, or 3 lymphedema
- •Proficiency in English language
排除标准
- •Patients with clotting disorders, venous insufficiency, end-stage lymphedema unless they are on the non-surgical arm.
- •Additionally, if the patient refuses to complete questionnaires, the patient will be excluded from the study and replaced at the discretion of the principal or co-principal investigator.
结局指标
主要结局
Quality of Life
时间窗: up to 40 months
Questionnaire to assess quality of life changes
次要结局
未报告次要终点
研究者
研究点 (3)
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