Prospective Observational Lymphoedema Intensive Treatment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01864044

Acronym

POLIT

Enrollment

306

Registered

2013-05-29

Start date

2009-09-30

Completion date

2012-12-31

Last updated

2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoedema

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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)

Exclusion criteria

* bilateral lymphedema, * lymphedema of both upper and lower limbs, * intensive decongestive therapy in the previous 6 months, * cancer recurrence, * systolic pressure index \< 0.5

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results