Evaluation Between Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy (CDT) Alone (LIPLEG)

Hautklinik Darmstadt

Status: Active, not recruiting

Conditions: Lipedema

Treatments: Procedure: Liposuction

Study type: Interventional

Funder types: Other

Identifiers

NCT04272827

LIPLEG-3806

Details and patient eligibility

About

The purpose of this study is to determine whether surgical treatment of lipedema (stage I, II or III) using liposuction significantly improves leg pain compared to the use of complex decongestive therapy (CDT).

Full description

After being informed about the study and potential risks, all patients that gave written informed consent will undergo a run-in phase of up to seven months for edema elimination and maintenance of results using complex decongestive therapy (CDT). Afterwards, patients will be assigned to one of the two treatment groups via internet randomization, provided that all inclusion and exclusion criteria continue to be met. Randomization will be 2:1 (intervention: control). In the intervention arm, patients will receive liposuction treatment (number of surgeries at the discretion of the treating study physician: a maximum of four surgical procedures, with a minimum of 5 and a maximum of 7 weeks between each surgery) with, if necessary, concomitant CDT to maintain the surgical results as required by the patient.

The primary endpoint (regarding pain in the legs in stages I, II or III) will be assessed after an observation period of 12 months after final liposuction surgery. This is followed by a further follow-up period for 24 months to observe and document the further course.

Enrollment: 450 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent form
2. Female
3. Age ≥ 18 years
4. Confirmed lipedema of the legs in stage I, II or III
5. Average pain in the legs for the last four weeks ≥ 4 points on a numerical rating scale
6. Documentation of insufficient relief of symptoms by conservative measures
7. Willingness and ability to perform conservative measures according to the study protocol, during and, if necessary, after liposuction treatment
8. Full legal capacity

Exclusion criteria

1. Concurrent lipedema of the arms and legs, in which co-occurrence of lipedema in the arms affects the primary endpoint (i.e., average leg pain), at the discretion of the study investigator
2. Previous liposuctions
3. Diseases that may limit operability at the discretion of the study physician, e.g. cardiac diseases, coagulation disorders, metabolic diseases, infectious diseases (active), epilepsy; diseases requiring immunosuppression or anticoagulation with medication; allergies to medication accompanying surgery
4. Weight >120.0 kg
5. Medical conditions that affect adequate complex decongestive therapy (CDT) at the discretion of the study physician, e.g. heart failure (volume stress), lack of physical ability to wear compression stockings (e.g. joint disease, neurological deficits).
6. Primary obesity without disproportion and without evidence of lipedema
7. Secondary obesity
8. Fat distribution disorders of other genesis (e.g. painless lipohypertrophy, benign symmetric lipomatoses or lipomatosis dolorosa)
9. Other edema-causing diseases (such as lymphedema, phlebedema, or myxedema)
10. Lack of willingness to ensure adequate contraception
11. Positive pregnancy test
12. Breastfeeding
13. Use of a lymphomat
14. Participation in other clinical studies
15. Purely cosmetic reasons for participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

In the intervention group, patients will receive liposuction treatment (number of surgeries at the discretion of the attending study physician: a maximum of 4 surgical procedures, with a minimum of 5 and a maximum of 7 weeks between each surgery) with concomitant complex decongestive therapy (CDT), if necessary, to maintain surgical outcomes as required by the patient.

Treatment:

Procedure: Liposuction

Control group

Other group

Description:

After randomisation, the control group will be treated for 12 months with complex decongestive therapy (CDT) alone. After these 12 months, patients can opt for liposuction treatment if they continue to meet the inclusion and exclusion criteria.

Treatment:

Procedure: Liposuction