Comparison of reconstructive surgery versus no surgery, additional to decongestive lymphatic therapy (usual care), for the treatment of lymphoedema, through a multicentre 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 possibly 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.
> CarEdOn primary researchers: Prof. Nele Devoogdt
> Research partners: Dr. Tessa De Vrieze, Dept. of Rehabilitation Sciences, KU Leuven and University of Antwerp (Belgium), Dr. Tessa De Vrieze, dpt of rehabilitation sciences, KU Leuven (Belgium), Drs. An-Kathleen Heroes, center for lymphoedema, UZ Leuven (Belgium), Dr. Sarah Thomis, center for lymphedema, University Hospitals Leuven (Belgium), Dr. Katarina Segers, dpt of plastic and reconstructive surgery, University Hospitals Leuven (Belgium), Prof. Lode Godderis, environment and health, KU Leuven (Belgium), Dr. Steffen Fieuws, Leuven biostatistics and statistical bioinformatics center, KU Leuven (Belgium), Prof. Caren Randon, dr. Chris Monten, prof. Koen Van Landuyt, dr. Bernard depypere, dr. Liesl de Graeve, mrs. Vickie Van Besien, dr. Tina Decorte, UZ Gent (Belgium), Prof. Thierry Deltombe, dr. Philippe Fosseprez, dr. Maxime Servaes and mrs. Jacqueline Frippiat, CHU-UCL Mont-Godinne (Belgium)
> Funding: Federaal Kenniscentrum voor de Gezondheidszorg (KCE19-1245)
> Keywords: primary edema, secondary edema, breast cancer, prostate cancer, melanoma, gynaecological cancer, manual lymphatic drainage, compression therapy, lymphatic surgery, exercise therapy, educational interventions, edema, upper limb function, near-infrared fluorescence imaging
With the support of the Belgian Health Care Knowledge Centre