Lipedema Clinical Trial
Official title:
Surgical Treatment of Lipedema in Norway - a National Multicenter Study
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.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Haraldsplass Deaconess Hospital | Bergen |
Lead Sponsor | Collaborator |
---|---|
Haraldsplass Deaconess Hospital | Helse Vest, Klinbeforsk, St. Olavs Hospital, Sykehuset Telemark, University Hospital of North Norway, University of Bergen |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Adverse effect of liposuction | Assess possible adverse effects of liposuction | 12 months after last liposuction surgery | |
Other | 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 | |
Primary | 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 | |
Secondary | 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 |
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