Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema
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 p
| Condition(s) | Lymphoedema of Leg, Lymphedema Arm, Lymphedema |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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?' |
| Who can participate | 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 ≥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 lymp |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
| Locations | Ghent, Belgium; Leuven, Belgium; Namur, Belgium |
| Start date | 2022-02-01 |
| NCT ID | NCT05064176 |
| Official listing | https://clinicaltrials.gov/study/NCT05064176 |