Effectiveness of Adding Reconstructive Lymphatic Surgery to Usual Decongestive Therapy for Treating Upper or Lower Limb Lymphoedema in Adults

What this Trial Is About

This research is investigating the added value of reconstructive lymphatic surgery in patients with upper or lower limb lymphoedema. The study compares this surgery combined with usual care, called decongestive lymphatic therapy, to usual care alone. The goal is to see if surgery improves lymphoedema-specific quality of life 18 months after treatment. Lymphoedema is a chronic condition causing limb swelling and physical and mental challenges, impacting daily function and work ability. Participants are randomly assigned to one of two groups one group receives reconstructive lymphatic surgery, which may include lymphovenous anastomosis, lymph node transfer, or both, plus usual care. The other group receives usual care alone, consisting of maintenance decongestive lymphatic therapy including skin care, compression garments, exercises, and manual lymph drainage. Surgery choice is based on each patients condition following a surgical algorithm. During the study, participants will undergo assessments at various time points up to 36 months. These include quality of life questionnaires, limb volume measurements, physical activity monitoring, work capacity evaluations, and tracking of compression garment use. Researchers will also monitor infections, surgery complications, lymphatic transport, and costs related to lymphoedema. The main outcome is quality of life related to lymphoedema at 18 months. Follow-up continues to evaluate longer-term effects and safety.

Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema