The National Lipedema Study

Not Applicable

Recruiting

• Conditions: Lipedema
• Interventions: Procedure: Liposuction early; Other: Standard conservative treatment; Procedure: Liposuction late; Other: Standard conservative treatment with Intermittent Pneumatic Compression (IPC)

• Registration Number: NCT05284266
• Lead Sponsor: Haraldsplass Deaconess Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-08
• Study Start: 2022-03-11
• Study First Posted: 2022-03-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical group: Liposuction	Liposuction early	Early liposuction, 6-9 months after inclusion in study.
Standard conservative treatment	Standard conservative treatment	Standard conservative treatment consisting of: * Physical therapy, including compression garment and exercise program * Self-care program * Individual counseling from a clinical dietician
Surgical group: Control	Liposuction late	Late liposuction, 18-21 months after inclusion. This group functions as a control group for 1 year before enrolment in the Liposuction group.
Standard treatment plus additional lymphedema treatment	Standard conservative treatment with Intermittent Pneumatic Compression (IPC)	Standard conservative treatment consisting of: * Physical therapy, including compression garment and exercise program * Self-care program * Individual counseling from a clinical dietician Additional lymphedema treatment consisting of intermittent pneumatic compression (IPC)

Primary Outcome Measures

Name	Time	Method
Effect of liposuction on lipedema pain	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).

Secondary Outcome Measures

Name	Time	Method
Effect of liposuction on quality of life and everyday activities for patients with lipedema	12 months after the last liposuction surgery	Assess the effect of liposuction on quality of life and everyday activities (RAND-36)

Trial Locations

Locations (1)

Haraldsplass Deaconess Hospital; 🇳🇴 Bergen, Norway