Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
220 participants
INTERVENTIONAL
2022-03-11
2027-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard conservative treatment
Standard conservative treatment consisting of:
* Physical therapy, including compression garment and exercise program
* Self-care program
* Individual counseling from a clinical dietician
Standard conservative treatment
Standard Conservative treatment consisiting of:
Physical therapy, including compression garment and exercise program, Self-care program
Standard treatment plus additional lymphedema treatment
Standard conservative treatment consisting of:
* Physical therapy, including compression garment and exercise program
* Self-care program
* Individual counseling from a clinical dietician Additional lymphedema treatment consisting of intermittent pneumatic compression (IPC)
Standard conservative treatment with Intermittent Pneumatic Compression (IPC)
Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC)
Surgical group: Liposuction
Early liposuction, 6-9 months after inclusion in study.
Liposuction early
Liposuction 6-9 months after inclusion
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 late
Liposuction 18-21 months after inclusion
Interventions
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Liposuction early
Liposuction 6-9 months after inclusion
Liposuction late
Liposuction 18-21 months after inclusion
Standard conservative treatment
Standard Conservative treatment consisiting of:
Physical therapy, including compression garment and exercise program, Self-care program
Standard conservative treatment with Intermittent Pneumatic Compression (IPC)
Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC)
Eligibility Criteria
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Inclusion Criteria
* age 20-65 years
* significant pain from lipedema
* lipedema stage 1-2 or localized stage 3
Exclusion Criteria
* pregnancy
* current malignancy
* previous surgical treatment for lipedema
* smoking
* BMI \> 28
* serious comorbidities such as cardiac-, pulmonary-, renal disease
* unwillingness to wear compression garments
20 Years
65 Years
FEMALE
Yes
Sponsors
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St. Olavs Hospital
OTHER
University Hospital of North Norway
OTHER
Sykehuset Telemark
OTHER_GOV
University of Bergen
OTHER
Klinbeforsk
OTHER
Helse Vest
OTHER
Haraldsplass Deaconess Hospital
OTHER
Responsible Party
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Hildur Skuladottir
Medical Doctor, PhD
Principal Investigators
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Hildur Skuladottir, PhD
Role: PRINCIPAL_INVESTIGATOR
Haraldsplass Deaconess Hospital
Locations
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Haraldsplass Deaconess Hospital
Bergen, , Norway
Countries
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Other Identifiers
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239087
Identifier Type: -
Identifier Source: org_study_id
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