A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 6
- 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.
研究组 & 干预措施
vascularized lymph node transfer (VLNT)
This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.
干预措施: Quality of Life Assessments (Behavioral)
non-surgical treatment
This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.
干预措施: Quality of Life Assessments (Behavioral)
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