NCT05284266

The National Lipedema Study

Surgical Treatment of Lipedema in Norway - a National Multicenter Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Haraldsplass Deaconess Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lipedema

Interventions

Type	Name	Description
PROCEDURE	Liposuction early	Liposuction 6-9 months after inclusion
PROCEDURE	Liposuction late	Liposuction 18-21 months after inclusion
OTHER	Standard conservative treatment	Standard Conservative treatment consisiting of: Physical therapy, including compression garment and exercise program, Self-care program
OTHER	Standard conservative treatment with Intermittent Pneumatic Compression (IPC)	Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC)

Timeline

• Start date: 2022-03-11
• Primary completion: 2026-10-31
• Completion: 2027-12-31
• First posted: 2022-03-17
• Last updated: 2025-09-22

Locations

1 site across 1 country: Norway