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Clinical Trials/NCT05284266
NCT05284266Active, not recruitingNot Applicable

Surgical Treatment of Lipedema in Norway - a National Multicenter Study

Haraldsplass Deaconess Hospital1 site in 1 country220 target enrollmentStarted: March 11, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
220
Locations
1
Primary Endpoint
Effect of liposuction on lipedema pain

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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
  • BMI > 28
  • serious comorbidities such as cardiac-, pulmonary-, renal disease
  • unwillingness to wear compression garments

Arms & Interventions

Standard conservative treatment

Active Comparator

Standard conservative treatment consisting of:

  • Physical therapy, including compression garment and exercise program
  • Self-care program
  • Individual counseling from a clinical dietician

Intervention: Standard conservative treatment (Other)

Standard treatment plus additional lymphedema treatment

Experimental

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)

Intervention: Standard conservative treatment with Intermittent Pneumatic Compression (IPC) (Other)

Surgical group: Liposuction

Experimental

Early liposuction, 6-9 months after inclusion in study.

Intervention: Liposuction early (Procedure)

Surgical group: Control

Active Comparator

Late liposuction, 18-21 months after inclusion. This group functions as a control group for 1 year before enrolment in the Liposuction group.

Intervention: Liposuction late (Procedure)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Effect of liposuction on quality of life and everyday activities for patients with lipedema(12 months after the last liposuction surgery)

Investigators

Sponsor
Haraldsplass Deaconess Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hildur Skuladottir

Medical Doctor, PhD

Haraldsplass Deaconess Hospital

Study Sites (1)

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