Lipedema
Conditions
Keywords
Liposuction, Conservative treatment, Intermittent pneumatic compression, Lipoedema, Compression therapy, Self management, Dietary management
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.
Interventions
Standard Conservative treatment consisiting of: Physical therapy, including compression garment and exercise program, Self-care program
PROCEDURELiposuction early
Liposuction 6-9 months after inclusion
PROCEDURELiposuction late
Liposuction 18-21 months after inclusion
OTHERStandard conservative treatment with Intermittent Pneumatic Compression (IPC)
Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC)
Sponsors
St. Olavs Hospital
University Hospital of North Norway
Sykehuset Telemark
University of Bergen
Klinbeforsk
Helse Vest
Haraldsplass Deaconess Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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 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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of different conservative treatments on lipedema pain and quality of life and everyday activities for patients with lipedema | 6 months after inclusion | Effect of two different conservative treatments strategies on pain and everyday activities (RAND-36) |
| Adverse effect of liposuction | 12 months after last liposuction surgery | Assess possible adverse effects of liposuction |
| Effect of liposuction on the need for conservative treatment | 3 years after last liposuction surgery | Assess whether having undergone liposuction changes the need for conservative treatment. |
Countries
Norway
Outcome results
None listed