Prospective Observational Lymphoedema Intensive Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Thuasne
- 入组人数
- 306
- 主要终点
- Change from baseline in affected limb volume
研究概览
简要总结
The aim of this observational study was to describe usual practices in lymphedema management in France.
It was the opportunity to assess the effects of these practices on lymphedema volume in a large number of patients, to identify predictive factors of response, and to assess the safety of this therapy.
详细描述
Lymphoedema is commonly treated according a strategy called Complex Decongestive Therapy (CDT). This CDT is usually composed of 2 different treatment phases. The first phase is an acute phase which aim is to reduce affected limb volume. The second phase is a maintenance phase which aim is to maintain as long as possible the volume reduction acheived during the first phase.
These 2 phases required multi modal parameters such as bandages, lymphatic drainages, physical exercises...and can be managed very differently from one site to another.
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
- •consecutive adult patients
- •hospitalized with a clinical diagnosis of unilateral stage II-III upper or lower limb lymphoedema of any etiology
- •indication for intensive decongestive therapy (IDT)
排除标准
- •bilateral lymphedema,
- •lymphedema of both upper and lower limbs,
- •intensive decongestive therapy in the previous 6 months,
- •cancer recurrence,
- •systolic pressure index < 0.5
结局指标
主要结局
Change from baseline in affected limb volume
时间窗: At the end of 1st phase of Complex Decongestive Therapy and 6 months later
According to the site, the first phase can lasts 1, 2 or 3 weeks.
次要结局
未报告次要终点