Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema (SurLym)
Lymphoedema of Leg, Lymphedema Arm, Lymphedema
About this trial
This is an interventional treatment trial for Lymphoedema of Leg focused on measuring Reconstructive lymphatic surgery, Decongestive lymphatic therapy, Lymphovenous anastomosis, Lymph node transfer
Eligibility Criteria
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 lymphoedema)
- History of at least 6 months of decongestive lymphatic therapy (DLT) until minimal pitting
- Age ≥ 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
Sites / Locations
- Ghent University HospitalRecruiting
- University Hospitals of Leuven, center for lymphedemaRecruiting
- CHU-UCL Mont-GodinneRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Reconstructive lymphatic surgery
No surgery
The intervention treatment is reconstructive lymphatic surgery and consists of the application of lymphovenous anastomosis (LVA), lymph node transfer (LNT) or a combination of both. The choice of reconstructive technique(s) is determined by the surgeon and is based on the algorithm for reconstructive lymphatic surgery of lymphoedema. Additionally, all patients receive usual care (i.e. maintenance decongestive lymphatic therapy)
All patients receive usual care (i.e. maintenance decongestive lymphatic therapy)