The National Lipedema Study
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bergen, Norway, 5009
- Haraldsplass Deaconess Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Surgical group: Liposuction
Early liposuction, 6-9 months after inclusion in study.
|
Liposuction 6-9 months after inclusion
|
|
Active Comparator: Standard conservative treatment
Standard conservative treatment consisting of:
|
Standard Conservative treatment consisiting of: Physical therapy, including compression garment and exercise program, Self-care program |
|
Experimental: Standard treatment plus additional lymphedema treatment
Standard conservative treatment consisting of:
|
Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC)
|
|
Active Comparator: Surgical group: Control
Late liposuction, 18-21 months after inclusion.
This group functions as a control group for 1 year before enrolment in the Liposuction group.
|
Liposuction 18-21 months after inclusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of liposuction on lipedema pain
Time Frame: 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).
|
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
Time Frame: 12 months after the last liposuction surgery
|
Assess the effect of liposuction on quality of life and everyday activities (RAND-36)
|
12 months after the last liposuction surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of different conservative treatments on lipedema pain and quality of life and everyday activities for patients with lipedema
Time Frame: 6 months after inclusion
|
Effect of two different conservative treatments strategies on pain and everyday activities (RAND-36)
|
6 months after inclusion
|
|
Adverse effect of liposuction
Time Frame: 12 months after last liposuction surgery
|
Assess possible adverse effects of liposuction
|
12 months after last liposuction surgery
|
|
Effect of liposuction on the need for conservative treatment
Time Frame: 3 years after last liposuction surgery
|
Assess whether having undergone liposuction changes the need for conservative treatment.
|
3 years after last liposuction surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hildur Skuladottir, PhD, Haraldsplass Deaconess Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 239087
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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