SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema.

Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Th... Mehr ...

Verfasser: Devoogdt, Nele
De Vrieze, Tessa
Heroes, An-Kathleen
Bechter-Hugl, Beate
Fieuws, Steffen
Godderis, Lode
Segers, Katarina
Maleux, Geert
Deltombe, Thierry
FRIPPIAT, Jacqueline
SERVAES, Maxime
Berners, Aline
Fosseprez, Philippe
Krug, Bruno
Kayser, Françoise
Falticeanu, Ana Andreea
Randon, Caren
Monten, Chris
Van Landuyt, Koen
De Pypere, Bernard
Degraeve, Liesl
Decorte, Tina
De Schryver, Mieke
Van Besien, Vickie
Devos, Daniel
Suominen, Sinikka
Ayala, Jaume Masia
Pons, Gemma
Fourneau, Inge
Thomis, Sarah
Dokumenttyp: Artikel
Erscheinungsdatum: 2024
Schlagwörter: Humans / Lymphedema / Quality of Life / Plastic Surgery Procedures / Pragmatic Clinical Trials as Topic / Belgium / Multicenter Studies as Topic / Leg / Plastic & reconstructive surgery / VASCULAR SURGERY / Vascular medicine
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-28928985
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : http://hdl.handle.net/2078.1/287543

Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema. A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). 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 at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient's own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased. The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and ...