The goal of this randomized controlled trial is to compare the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients suffering from unilateral cancer-related lymphedema in either the upper or lower extremity. It aims to answer whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score.
A total of 110 participants will be allocated randomly into two groups at a 1:1 ratio. The first group will receive lymphaticovenous anastomosis (LVA), while the second group will undergo sham surgery.
Treated for cancer and underwent treatment of either axillary or inguinal lymph nodes or radiotherapy;
Early stage lymphedema (ISL I-II) in the upper or lower extremity, and diagnosed by lymphoscintigraphy for the lower extremity;
Unilateral lymphedema;
Viable lymphatic vessels as determined by indocyanine green (ICG)Lymphography (stage II-III);
History of lymphatic reconstruction in the past 10 years;
Late-stage lymphedema of the extremity (ISL classification ≥ II lymphedema) with evident fat deposition and/or fibrosis;
Patients with active distant metastases, treated with palliative intent;
Patients with the active treatment of primary cancer, i.e. surgery, radiotherapy, and/or chemotherapy. Note: patients receiving adjuvant targeted and/or endocrine treatment are eligible;
Maastricht University Medical Center
Lead sponsor
Radboud University Medical Center
Collaborator
Erasmus Medical Center
Collaborator