Comparison of reconstructive surgery versus no surgery, additional to decongestive lymphatic therapy (usual care), for the treatment of lymphoedema, through a multicentre, pragmatic randomised controlled trial

Lymphoedema is a chronic and often debilitating condition caused by lymphatic insufficiency. It leads to swelling of the limb and an increased risk of infection. It can be classified as primary (congenital) or secondary (acquired) lymphoedema.

Lymphoedema is very burdensome for the patient and therefore is it often associated with mental problems for example frustration and stress. In addition, because of the increase in volume of the limb, patients also develop physical problems, such as pain, heaviness, loss of strength, and develop functional problems, such as problems with household, mobility or social activities. These mental, physical and functional problems all have a negative impact on quality of life and have an influence on the ability to work. Consensus exist that the first choice of treatment is a conservative treatment. This conservative treatment consists of skin care, compression therapy (i.e. multilayer bandaging and compression garments), exercises and lymph drainage. Reconstructive surgery is another option, also often performed: i.e. lymphovenous anastomoses, on the one hand, and a lymph node transfer, on the other hand. By (partially) restoring the lymphatic transport, the reconstructive surgery may possibly lead to a larger decrease of the lymphoedema volume and therefore greater discontinuation of the compression garment. Consequently, patients will have an improvement in functioning and quality of life.

Currently, scientific evidence for reconstructive surgery for the treatment of lymphoedema is missing. Therefore, the aim of this trial is to investigate the added value of reconstructive surgery of the lymphatic system in addition to the conservative treatment, for the treatment of lymphoedema.

Summary:

Participants (P): Subjects with primary or secondary upper or lower limb lymphoedema stage 1 to 2b

Intervention (I): Reconstructive surgery: LVA or LNT or combination, added to usual care

Control (C): Usual care (no surgery)

Outcome (O): Lymphoedema-specific QOL, at 18 months post-baseline

Trial Design: Multicentre, pragmatic randomised controlled trial

Sample Size: 180 patients

Trial duration: 48 months to CSR I with an additional 17 months to CSR II after FU

Budget: €1,800,000 (€ 1,600,000 for study and € 200,000 for non-reimbursed surgery costs)