Prospective Observational Lymphoedema Intensive Treatment
- Conditions
- Lymphoedema
- Registration Number
- NCT01864044
- Lead Sponsor
- Thuasne
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
- 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)
- bilateral lymphedema,
- lymphedema of both upper and lower limbs,
- intensive decongestive therapy in the previous 6 months,
- cancer recurrence,
- systolic pressure index < 0.5
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in affected limb volume 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.
- Secondary Outcome Measures
Name Time Method