Prospective Observational Lymphoedema Intensive Treatment (POLIT)

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.

Study Overview

• Status: Completed
• Conditions: Lymphoedema

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.

• Study Type: Observational
• Enrollment (Actual): 306

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All consecutive adult patients hospitalized with a clinical diagnosis of unilateral stage II-III upper or lower limb lymphoedema of any etiology and an indication for intensive decongestive therapy (IDT) were enrolled.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in affected limb volume	According to the site, the first phase can lasts 1, 2 or 3 weeks.	At the end of 1st phase of Complex Decongestive Therapy and 6 months later

Collaborators and Investigators

• Sponsor: Thuasne

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: May 23, 2013
• First Posted (Estimated): May 29, 2013

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: EC07