Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema
Recruiting now · Not applicable
Conditions studied: Lymphoedema of Leg, Lymphedema Arm, Lymphedema
In brief
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?'
Key facts
- Study ID
- NCT05064176
- Run by
- Universitaire Ziekenhuizen KU Leuven
- People needed
- 180
- Starts
- 2022-02-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2024-07-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Unilateral or bilateral, primary or secondary lymphoedema of the upper or lower limb
- If cancer-related lymphoedema, approval for participation in study from oncological specialist (patient participation has to be discussed during Multidisciplinary Oncological Consult); approval if:
- estimated cancer-related survival is ≥3 years
- oncological safety is guaranteed: for instance, time interval since radiotherapy/ chemotherapy is ≥3 months
- Lymphoedema stage 1 to 2b
- Objective diagnosis of lymphoedema: ≥ 5% volume difference OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of IndoCyanineGreen (ICG) dermal backflow
- Score on Lymph-ICF questionnaire at screening: ≥ 25 / 100 (= moderate level of problems in functioning related to the development of lymphoedema)
- History of at least 6 months of decongestive lymphatic therapy (DLT) until minimal pitting
- Age ≥ 18 years
You may not qualify if…
- Participants with history of liposuction, lymphovenous anastomosis, lymph node transfer
- Pregnant participants
- Severe obese participants: BMI>35
- Estimated cancer-related survival is <3 years and oncological safety is not guaranteed (e.g. interval since radiotherapy/ chemotherapy is <3 months)
- In case of lower limb lymphoedema: presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome
- Allergy for ICG, iodine, penicillin and sulphonamides; increased activity of thyroid gland; benign tumour in thyroid; heparin use and severe renal insufficiency
Where it is running
- Ghent University Hospital — Ghent, Belgium (enrolling)
- University Hospitals of Leuven, center for lymphedema — Leuven, Belgium (enrolling)
- CHU-UCL Mont-Godinne — Namur, Belgium (enrolling)
Full record on ClinicalTrials.gov
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