Clinical trial NCT05284266: The National Lipedema Study
Official title: Surgical Treatment of Lipedema in Norway - a National Multicenter Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lipedema
Keywords: Liposuction
Conservative treatment
Intermittent pneumatic compression
Lipoedema
Compression therapy
Self management
Dietary management
Lead sponsor: Haraldsplass Deaconess Hospital
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: University Hospital of North Norway
name: Sykehuset Telemark
name: University of Bergen
name: Klinbeforsk
name: Helse Vest
First posted: 2022-03-17
Enrollment: 220
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Effect of liposuction on lipedema pain
timeFrame: 12 months after the last liposuction surgery
Secondary outcomes:
measure: Effect of liposuction on quality of life and everyday activities for patients with lipedema
timeFrame: 12 months after the last liposuction surgery
Other outcomes:
measure: Effect of different conservative treatments on lipedema pain and quality of life and everyday activities for patients with lipedema
timeFrame: 6 months after inclusion
measure: Adverse effect of liposuction
timeFrame: 12 months after last liposuction surgery
measure: Effect of liposuction on the need for conservative treatment
timeFrame: 3 years after last liposuction surgery
Locations:
city: Bergen
country: Norway
facility: Haraldsplass Deaconess Hospital
Study officials:
affiliation: Haraldsplass Deaconess Hospital
name: Hildur Skuladottir, PhD
role: PRINCIPAL_INVESTIGATOR
References: