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The National Lipedema Study
Sponsor: Haraldsplass Deaconess Hospital
Summary
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.
Official title: Surgical Treatment of Lipedema in Norway - a National Multicenter Study
Key Details
Gender
FEMALE
Age Range
20 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2022-03-11
Completion Date
2027-12-31
Last Updated
2025-09-22
Healthy Volunteers
Yes
Conditions
Interventions
Liposuction early
Liposuction 6-9 months after inclusion
Liposuction late
Liposuction 18-21 months after inclusion
Standard conservative treatment
Standard Conservative treatment consisiting of: Physical therapy, including compression garment and exercise program, Self-care program
Standard conservative treatment with Intermittent Pneumatic Compression (IPC)
Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC)
Locations (1)
Haraldsplass Deaconess Hospital
Bergen, Norway