Actively Recruiting
Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
180
Participants Needed
3
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this research proposal is to investigate * in patients with lymphoedema of the upper limb or lower limb (P) * the added value of reconstructive lymphatic surgery (I) * to the decongestive lymphatic therapy (usual care) (C) * on the lymphoedema-specific quality of life (QoL) (O) * at 18 months post-surgery/ no surgery (T) Consequently, a multicentre pragmatic randomised controlled trial is performed to give an answer on following research question: 'Is, in addition to usual care - i.e. decongestive lymphatic therapy -, reconstructive lymphatic surgery (intervention group) superior to no surgery (control group), for the treatment of upper or lower limb lymphoedema?'
CONDITIONS
Official Title
Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral or bilateral, primary or secondary lymphoedema of the upper or lower limb
- If cancer-related lymphoedema, approval from oncological specialist with estimated survival of at least 3 years and oncological safety guaranteed (e.g., at least 3 months since radiotherapy/chemotherapy)
- Lymphoedema stage 1 to 2b
- Objective diagnosis of lymphoedema: 5% or more volume difference OR 2 minor or 1 major criteria on lymphoscintigraphy OR presence of IndoCyanineGreen dermal backflow
- Lymph-ICF questionnaire score of 25 or higher
- History of at least 6 months of decongestive lymphatic therapy until minimal pitting
- Age 18 years or older
You will not qualify if you...
- History of liposuction, lymphovenous anastomosis, or lymph node transfer
- Pregnant participants
- Severe obesity with BMI over 35
- Estimated cancer-related survival less than 3 years or oncological safety not guaranteed (e.g., less than 3 months since radiotherapy/chemotherapy)
- For lower limb lymphoedema: chronic venous insufficiency stages C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome
- Allergy to ICG, iodine, penicillin, or sulphonamides
- Increased thyroid gland activity or benign thyroid tumor
- Use of heparin or severe kidney failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Ghent University Hospital
Ghent, Belgium
Actively Recruiting
2
University Hospitals of Leuven, center for lymphedema
Leuven, Belgium, 3000
Actively Recruiting
3
CHU-UCL Mont-Godinne
Namur, Belgium
Actively Recruiting
Research Team
N
Nele Devoogdt
CONTACT
T
Tessa De Vrieze
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here