Project description
Introduction
Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb and an increased risk of infection. Lymphoedema is very burdensome for the patient and is often associated with mental and physical problems that have a negative impact on quality of life and have an influence on the ability to work. Consensus exists that the first choice of treatment is a conservative treatment, consisting of skin care, compression garments, exercises and lymphatic drainage. Reconstructive lymphatic surgery is also often performed, i.e. lymphovenous anastomoses (LVA), lymph node transfer (LNT), or a combination of both. Currently, scientific evidence for reconstructive lymphatic surgery for the treatment of lymphoedema is missing. Therefore, the main objective of this trial is to investigate in patients with lymphoedema the added value of reconstructive lymphatic surgery in addition to the conservative treatment for the treatment of lymphoedema.
Methods
A multicentre randomised controlled and pragmatic trial has been started in March 2022 in 3 university hospitals in Belgium. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised in an intervention group receiving reconstructive lymphatic surgery and conservative treatment or a control group receiving only conservative treatment. Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment during 1 week at 18 months. Other secondary outcomes are related to health-related quality of life, experience of compression garment, physical activity level, infection rate, recurrence of cancer, complications of surgery, costs related to lymphoedema and its treatment, intensive treatment and lymphatic function. As reconstructive lymphatic surgery, trained surgeons perform LVA, LNT or combination of both. The choice is based on pre-surgical investigations, i.e. lymphofluoroscopy, lymphoscintigraphy, lymph MRI (in case of LVA) and clinical examination and CT angiography (in case of LNT). Regarding the conservative treatment, from month 1 to 6, the patient goes to his/ her home physical therapist and performs self-management. From month 7 to 12, the patient continues conservative treatment, but the hours a day of wearing the compression garment is gradually decreased from 16h/day at the end of month 6 to 0h/day at the end of month 12. The limb volume is evaluated weekly and if it increases, the duration of wearing the compression garment is increased again. From month 13 to 18, the patient only performs self-management. From month 19 to 36, the patient is further followed and may choose whether he/ she follows physical therapist sessions or only performs self-management.
Ethics and dissemination
The study will be conducted in accordance with the Declaration of Helsinki. This protocol has been approved by the ethical committee of the University Hospitals of Leuven and participating centres.
ClinicalTrials.gov Identifier: NCT05064176
Partners
Nele Devoogdt (University Hospitals Leuven, Department of Vascular Surgery, Center for Lymphedema, Leuven, Belgium); Tessa De Vrieze (KU Leuven – University of Leuven, Department of Rehabilitation Sciences, Leuven, Belgium); An-Kathleen Heroes (KU Leuven – University of Leuven, Department of Rehabilitation Sciences, Leuven, Belgium); Beate Bechter-Hugl (University Hospitals Leuven, Department of Vascular Surgery, Center for Lymphedema, Leuven, Belgium); Steffen Fieuws (KU Leuven – University of Leuven, Leuven Biostatistics and Statistical Bioinformatics Centre (L-BioStat), Leuven, Belgium); Lode Godderis (KU Leuven – University of Leuven, Centre for Environment and Health, Leuven, Belgium); Katarina Segers (University Hospitals Leuven, Department of Plastic and Reconstructive Surgery, Leuven, Belgium); Geert Maleux (University Hospitals Leuven, Department of Radiology, Leuven, Belgium); Sarah Thomis (University Hospitals Leuven, Department of Vascular Surgery, Center for Lymphedema, Leuven, Belgium); Inge Fourneau (University Hospitals Leuven, Department of Vascular Surgery, Center for Lymphedema, Leuven, Belgium)
Thierry Deltombe (CHU UCL Namur – Site Godinne, Department of Physical Medicine and Rehabilitation, Centre de Reference du Lymphoedeme, Yvoir, Belgium); Jacqueline Frippiat (CHU UCL Namur – Site Godinne, Department of Physical Medicine and Rehabilitation, Centre de Reference du Lymphoedeme, Yvoir, Belgium); Maxime Servaes CHU UCL Namur – Site St-Elisabeth, Department of Plastic and Reconstructive Surgery, Namur, Belgium); Aline Berners (CHU UCL Namur – Site St-Elisabeth, Department of Plastic and Reconstructive Surgery, Namur, Belgium); Philippe Fosseprez (CHU UCL Namur – Site St-Elisabeth, Department of Plastic and Reconstructive Surgery, Namur, Belgium); Francoise Kayser (CHU UCL Namur – Site Godinne, Department of Radiology, Yvoir, Belgium); Ana Falticeanu (CHU UCL Namur – Site Godinne, Department of Radiology, Yvoir, Belgium); Caren Randon (Ghent University Hospital, Department of Vascular Surgery, Lymphedema Clinic, Ghent, Belgium); Chris Monten (Ghent University Hospital, Department of Radiotherapy, Lymphedema Clinic, Ghent, Belgium); Koen Van Landuyt (Ghent University Hospital, Department of Plastic and Reconstructive Surgery, Lymphedema Clinic, Ghent, Belgium); Bernard De Pypere (Ghent University Hospital, Department of Plastic and Reconstructive Surgery, Lymphedema Clinic, Ghent, Belgium); Liesl Degraeve (Ghent University Hospital, Department of Plastic and Reconstructive Surgery, Lymphedema Clinic, Ghent, Belgium); Tina Decorte (Ghent University Hospital, Department of Physical Medicine and Rehabilitation, Lymphedema Clinic, Ghent, Belgium); Mieke De Schryver (Ghent University Hospital, Department of Physical Medicine and Rehabilitation, Lymphedema Clinic, Ghent, Belgium); Vickie Van Besien (Ghent University Hospital, Department of Physical Medicine and Rehabilitation, Lymphedema Clinic, Ghent, Belgium); Daniël Devos (Ghent University Hospital, Department of Radiology, Ghent, Belgium); Sinnika Suominen (Helsinki University Hospital, Department of Plastic Surgery, Helsinki, Finland); Jaume Masia (Hospital de la Santa Creu i Sant Pau and the Hospital del Mar of Barcelona, Department of Plastic Surgery, Barcelona, Spain); Gemma Pons (Hospital de la Santa Creu i Sant Pau and the Hospital del Mar of Barcelona, Department of Plastic Surgery, Barcelona, Spain)