Comparison of Reconstructive Lymphatic Surgery Versus no Surgery, Additional to Decongestive Lymphatic Therapy (Usual Care), for the Treatment of Iymphoedema, Through a Multicentre Randomised Controlled Trial
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?'
• 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