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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| University Hospital of North Norway | OTHER |
| Sykehuset Telemark | OTHER_GOV |
| University of Bergen |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard conservative treatment | Active Comparator | Standard conservative treatment consisting of:
|
|
| Standard treatment plus additional lymphedema treatment | Experimental | Standard conservative treatment consisting of:
|
|
| Surgical group: Liposuction | Experimental | Early liposuction, 6-9 months after inclusion in study. |
|
| Surgical group: Control | Active Comparator | Late liposuction, 18-21 months after inclusion. This group functions as a control group for 1 year before enrolment in the Liposuction group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposuction early | Procedure | Liposuction 6-9 months after inclusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of liposuction on lipedema pain | 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). | 12 months after the last liposuction surgery |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of different conservative treatments on lipedema pain and quality of life and everyday activities for patients with lipedema | Effect of two different conservative treatments strategies on pain and everyday activities (RAND-36) | 6 months after inclusion |
| Adverse effect of liposuction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hildur Skuladottir, PhD | Haraldsplass Deaconess Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haraldsplass Deaconess Hospital | Bergen | 5009 | Norway |
Data will be available after publication of outcomes.
Data will be available after publication of outcomes.
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| ID | Term |
|---|---|
| D065134 | Lipedema |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| OTHER |
| Klinbeforsk | OTHER |
| Helse Vest | OTHER |
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 are evaluated. 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.
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| Liposuction late |
| Procedure |
Liposuction 18-21 months after inclusion |
|
| Standard conservative treatment | Other | Standard Conservative treatment consisiting of: Physical therapy, including compression garment and exercise program, Self-care program |
|
| Standard conservative treatment with Intermittent Pneumatic Compression (IPC) | Other | Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC) |
|
Assess possible adverse effects of liposuction |
| 12 months after last liposuction surgery |
| Effect of liposuction on the need for conservative treatment | Assess whether having undergone liposuction changes the need for conservative treatment. | 3 years after last liposuction surgery |