Department of Dermatology, Medical Center Klinikum Darmstadt, Teaching Hospital Goethe-University Frankfurt, Grafenstr. 9, 64283, Darmstadt, Germany.
University of Cologne, Institute of Medical Statistics and Computational Biology, Faculty of Medicine and University Hospital Cologne, Robert-Koch-Str. 10, 50924, Cologne, Germany.
Trials. 2021 Oct 30;22(1):758. doi: 10.1186/s13063-021-05727-2.
Lipedema is a chronic disorder of the adipose tissue that affects mainly women, characterised by symmetrical, excessive fatty tissue on the legs and pain. Standard conservative treatment is long-term comprehensive decongestive therapy (CDT) to alleviate lipedema-related pain and to improve psychosocial well-being, mobility and physical activity. Patients may benefit from surgical removal of abnormally propagated adipose tissue by liposuction. The LIPLEG trial evaluates the efficacy and safety of liposuction compared to standard CDT.
METHODS/DESIGN: LIPLEG is a randomised controlled multicentre investigator-blinded trial. Women with lipedema (n=405) without previous liposuction will be allocated 2:1 to liposuction or CDT. The primary outcome of the trial is leg pain reduction by ≥2 points on a visual analogue scale ranging 0-10 at 12 months on CDT or post-completion of liposuction. Secondary outcomes include changes in leg pain severity, health-related quality of life, depression tendency, haematoma tendency, prevalence of oedema, modification physical therapy scope, body fat percentage, leg circumference and movement restriction. The primary analysis bases on intention-to-treat. Success proportions are compared using the Mantel-Haenszel test stratified by lipedema stage at a 5% two-sided significance level. If this test is statistically significant, the equality of the response proportions in the separate strata is evaluated by Fisher's exact test in a hierarchical test strategy.
LIPLEG assesses whether surgical treatment of lipedema is safe and effective to reduce pain and other lipedema-related health issues. The findings of this trial have the potential to change the standard of care in lipedema.
ClinicalTrials.gov NCT04272827. Registered on February 14, 2020.
Protocol version is 02_0, December 17, 2019.
脂肪营养不良是一种主要影响女性的慢性脂肪组织疾病，其特征是腿部出现对称性、过度脂肪组织和疼痛。标准的保守治疗是长期综合消肿治疗（CDT），以减轻脂肪营养不良相关的疼痛，并改善心理社会幸福感、移动性和身体活动能力。患者可能受益于通过吸脂术去除异常增生的脂肪组织。LIPLEG 试验评估了吸脂术与标准 CDT 相比的疗效和安全性。
方法/设计：LIPLEG 是一项随机对照多中心研究者盲法试验。将 405 名无既往吸脂术史的脂肪营养不良女性患者按照 2:1 的比例随机分配至吸脂术或 CDT 组。试验的主要结局是在 CDT 治疗 12 个月或吸脂术完成后，腿部疼痛减轻≥2 分，疼痛程度采用 0-10 分的视觉模拟量表评估。次要结局包括腿部疼痛严重程度、健康相关生活质量、抑郁倾向、血肿倾向、水肿发生率、物理治疗范围的改变、体脂百分比、腿部周长和运动受限的变化。主要分析基于意向治疗。使用 Mantel-Haenszel 检验，按脂肪营养不良分期进行分层，以 5%双侧显著性水平比较成功率比例。如果该检验具有统计学意义，则采用 Fisher 精确检验在分层检验策略中评估各分层中反应比例的均等性。
LIPLEG 评估了手术治疗脂肪营养不良是否安全有效，可以减轻疼痛和其他与脂肪营养不良相关的健康问题。该试验的结果有可能改变脂肪营养不良的治疗标准。
ClinicalTrials.gov NCT04272827。于 2020 年 2 月 14 日注册。
方案版本为 02_0，2019 年 12 月 17 日。
