The National Lipedema Study

Study Overview
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Brief Summary
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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 lipedemaand 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
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Surical Treatment of Lipedema in Norway - a National Multicenter Study

Conditions
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Lipedema

Intervention / Treatment
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* Procedure: Liposuction early
* Procedure: Liposuction late
* Other: Standard conservative treatment
* Other: Standard conservative treatment with Intermittent Pneumatic Compression (IPC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients are randomized to two different conservative treatment protocols;either standard conservative treatment (SCT) or standard treatment plus additional lymphedema treatment (intermittent pneumatic compression -IPC). After 6 months the effects of the conservative treatment areevaluated. Patients who still want surgery and fulfill the criteria are randomized (1:1) to early (cases(liposuction initiated 6-9 months after inclusion)) or late surgery (controls (liposuction initiated 18-21 months after inclusion)). Randomization to the surgical group is stratified by conservative treatment arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard conservative treatment<br>Standard Conservative treatment consisiting of: Physical therapy, includng Compression garment and exercise program Self-care program Individual counseling from a clinical dietician | Other: Standard conservative treatment<br>* Standard Conservative treatment consisiting of: Physical therapy, including compression garment and exercise program, Self-care program<br>|
| Experimental: Standard treatment plus additional lymphedema treatment<br>Standard Conservative treatment consisiting of: Physical therapy, includng Compression garment and exercise program Self-care program Individual counseling from a clinical dietician Additional lymphedema treatment consising of intermittent pneumatic compression (IPC) | Other: Standard conservative treatment with Intermittent Pneumatic Compression (IPC)<br>* Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC)<br>|
| Experimental: Surgical group: Liposuction<br>Early liposuction, 6-9 months after inclusion in study. | Procedure: Liposuction early<br>* Liposuction 6-9 months after inclusion<br>|
| Active Comparator: Srugical group: Control<br>Late liposuction, 18-21 months after inclusion. This group functions as a control group for 1 year before enrolment in the Liposuction group. | Procedure: Liposuction late<br>* Liposuction 18-21 months after inclusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of liposuction on lipedema pain | Assess the effect of liposuction on lipedema pain (Visual Analog Scale (VAS)). | 12 months after the last liposuction surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of liposuction on quality of life and everyday activities for patients with lipedema | Assess the effect of liposuction on quality of life and everyday activities (RAND-36) | 12 months after the last liposuction surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liposuction, Conservative treatment, Intermittent pneumatic compression, Lipoedema, Compression therapy, Self management, Dietary management