Department of Rehabilitation Sciences, KU Leuven - University of Leuven, Leuven, Belgium
Department of Vascular Surgery, Centre for Lymphedema, University Hospitals Leuven, Leuven, Belgium.
BMJ Open. 2024 May 10;14(5):e078114. doi: 10.1136/bmjopen-2023-078114.
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 presentations.
NCT05064176.
淋巴水肿是一种由淋巴功能不全引起的慢性疾病。它会导致肢体/中线区域肿胀，并增加感染的风险。淋巴水肿常伴有心理和身体问题，限制了生活质量。治疗的首选是保守治疗，包括运动、皮肤护理、淋巴引流和压迫。重建性淋巴手术也经常进行，即淋巴管静脉吻合术、淋巴结转移或两者结合。然而，关于重建性淋巴手术有效性的有力证据仍然缺乏。因此，本试验的目的是研究在淋巴水肿患者中，重建性淋巴手术对保守治疗的附加价值。
这是一项于 2022 年 3 月在比利时三家大学医院开始的多中心随机对照和实用试验。将纳入 90 例上肢淋巴水肿患者和 90 例下肢淋巴水肿患者。所有患者均随机分为单独保守治疗（对照组）或保守治疗联合重建性淋巴手术（干预组）。评估在基线时和 1、3、6、12、18、24 和 36 个月时进行。主要结局是 18 个月时的淋巴水肿特异性生活质量。关键次要结局是 18 个月时肢体体积和穿着压迫衣的时间。重建性淋巴手术的方法基于术前检查，包括临床检查、淋巴闪烁照相术、淋巴闪烁扫描、淋巴 MRI 或 CT 血管造影术（如有需要）。所有患者在 36 个月内接受保守治疗，由患者自己的物理治疗师和患者自己应用。从第 7 个月到第 12 个月，逐渐减少每天穿着压迫衣的时间。
该研究已获得鲁汶大学医院、根特大学医院和 CHU UCL Namur 的伦理委员会的批准。结果将通过同行评议的期刊和演讲进行传播。
NCT05064176。
