Upper limb lymphoedema is a common and often distressing side effect of breast cancer treatment. Reconstructive lymphatic microsurgery may be considered if conservative treatment fails but is highly specialized and expensive.
This phase two, pragmatic, randomized controlled trial will compare a novel surgical technique; lymph node grafting (LNG) in addition to standard lymphoedema therapy, against standard lymphoedema therapy alone. Study participants will be those with residual stage one to two breast-cancer related lymphoedema despite initial treatment with standard lymphoedema therapy.
The aim is to determine whether LNG plus standard lymphoedema therapy produces a greater reduction in lymphoedema volume (LV) and improved quality of life compared with the control group; standard lymphoedema therapy alone. A further aim is to demonstrate that LNG is a safe treatment, with acceptable surgical morbidity.
The procedure itself involves lymph node grafting from groin to upper limb. This technique is carried out by trained plastic and breast surgeons and involves an incision in the groin with removal of two lymph nodes under local anaesthetic. Lymph nodes are then grafted into the subcutaneous tissue of the elbow and wrist of the affected limb. Surgeons will have a minimum of five years experience. This surgery is carried out in one surgical procedure and takes approximately 60 minutes.
Key inclusion criteria
Key exclusion criteria
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