跳至主要内容
临床试验/NCT05284266
NCT05284266进行中(未招募)不适用

Surgical Treatment of Lipedema in Norway - a National Multicenter Study

Haraldsplass Deaconess Hospital2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2022年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
220
试验地点
2
主要终点
Effect of liposuction on lipedema pain

研究概览

简要总结

Lipedema is a chronic condition with a symmetrical accumulation of painful fatty tissue primarily affecting the limbs, sparing hands, feet and trunk. The subcutaneous fatty tissue is disproportionately voluminous and may have a different microstructure and metabolism than the patient's regular fatty tissue. The condition affects almost exclusively women and usually debuts around puberty. Lipedema seems to have a hereditary component, may be affected by hormonal variations and worsens with obesity. Guidelines advocate conservative treatment with compression therapy, weight management, physical activity, life style changes and psychological support;and in some cases surgical treatment such as bariatric surgery and liposuction.

Treatment of lipedema is indicated when the condition causes significant pain and inhibits the patient's everyday activities. Well-designed randomized controlled studies on lipedema are lacking.

The Ministry of Health and Care Services in Norway has found the scientific documentation for the effects of liposuction to be insufficient and has recommended that surgical treatment of lipedema should be evaluated through a 5-year clinical trial. A national task force, consisting of representatives from all four regional health authorities in Norway has been set up. This task force has now initiated this study. A national multi-center study with homogenous treatment protocols can provide globally sought insight on lipedema and the effect of its treatment regimes, and the findings will be important to adjust future treatment strategies regarding both effect and cost/effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age 20-65 years
  • significant pain from lipedema
  • lipedema stage 1-2 or localized stage 3

排除标准

  • Non-fluency in the Norwegian language
  • pregnancy
  • current malignancy
  • previous surgical treatment for lipedema
  • BMI > 28
  • serious comorbidities such as cardiac-, pulmonary-, renal disease
  • unwillingness to wear compression garments

结局指标

主要结局

Effect of liposuction on lipedema pain

时间窗: 12 months after the last liposuction surgery

Assess the effect of liposuction on lipedema pain (Visual Analog Scale (VAS). VAS consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (worst possible pain).

次要结局

  • Effect of liposuction on quality of life and everyday activities for patients with lipedema(12 months after the last liposuction surgery)

研究者

发起方
Haraldsplass Deaconess Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hildur Skuladottir

Medical Doctor, PhD

Haraldsplass Deaconess Hospital

研究点 (2)

Loading locations...

相似试验