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โ† Trials
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Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema

RecruitingNAAges 18 Years - anyAllUniversitaire Ziekenhuizen KU Leuven
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In plain words

What the trial is, and whether it could suit you

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?'

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 โ‰ฅ3 years * oncological safety is guaranteed: for instance, time interval since radiotherapy/ chemotherapy is โ‰ฅ3 months * Lymphoedema stage 1 to 2b * Objective diagnosis of lymphoedema: โ‰ฅ 5% volume difference OR โ‰ฅ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of IndoCyanineGreen (ICG) dermal backflow * Score on Lymph-ICF questionnaire at screening: โ‰ฅ 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 โ‰ฅ 18 years Exclusion Criteria: * 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
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What it tests

  • Usual care
  • Reconstructive lymphatic surgery
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Where

3 sites
Ghent University Hospital
Ghent, Belgium
University Hospitals of Leuven, center for lymphedema
Leuven, Belgium
CHU-UCL Mont-Godinne
Namur, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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