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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Multicentre, Controlled, Randomized, Investigator-blinded Clinical Trial on Efficacy and Safety of Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy Alone (LIPLEG)

Conditions
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Lipedema

Intervention / Treatment
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* Procedure: Liposuction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent form Female Age ≥ 18 years Confirmed lipedema of the legs in stage I, II or III Average pain in the legs for the last four weeks ≥ 4 points on a numerical rating scale Documentation of insufficient relief of symptoms by conservative measures Willingness and ability to perform conservative measures according to the study protocol, during and, if necessary, after liposuction treatment Full legal capacity Exclusion Criteria: 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 Previous liposuctions 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 Weight >120.0 kg 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). Primary obesity without disproportion and without evidence of lipedema Secondary obesity Fat distribution disorders of other genesis (e.g. painless lipohypertrophy, benign symmetric lipomatoses or lipomatosis dolorosa) Other edema-causing diseases (such as lymphedema, phlebedema, or myxedema) Lack of willingness to ensure adequate contraception Positive pregnancy test Breastfeeding Use of a lymphomat Participation in other clinical studies Purely cosmetic reasons for participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After a run in phase, randomization is performed in the intervention and control arm (2:1).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>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. | Procedure: Liposuction<br>* Liposuction treatment will be performed according to the study protocol using the wet technique depending on the amount of fat to be removed, if necessary in several sessions.<br>|
| Other: Control group<br>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. | Procedure: Liposuction<br>* Liposuction treatment will be performed according to the study protocol using the wet technique depending on the amount of fat to be removed, if necessary in several sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Pain Reduction After 12 Months (≥ 2 Points on a Numeric Rating Scale) | The primary end point is the relevant reduction of the average pain of the last four weeks in the legs (≥ 2 points on a Numeric Rating Scale; German Pain Questionnaire) 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation. | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Severity as Assessed by German Pain Questionnaire | Change in severity according to von Korff et al. (1992) regarding pain in the legs (stage I, II or III). The severity is calculated based on the questions of the German Pain Questionnaire according to von Korff et al (1992). The assessment of the pain intensity as well as the impairment and information on the days of impairment are included in the calculation of the severity (classes 0 = no pain to 4 = high, pain-related impairment, strongly limiting). | 12 months after completed liposuction treatment (intervention group) or after randomization (control group) compared with the time of randomisation) | 
| Change in Health-Related Quality of Life According to SF-36 Questionnaire | Change in health-related quality of life according to SF-36 questionnaire. | 12 months after completed liposuction treatment (intervention group) or after randomization (control group) compared with the time of randomisation) | 
| Change in Health-Related Quality of Life According to DLQI Questionnaire | Change in health-related quality of life according to DLQI questionnaire (a clinically relevant change corresponds to ≥ 4 points change in DLQI sum score). | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 
| Change in Health-Related Quality of Life According to WHOQOL-BREF Questionnaire | Change in health-related quality of life according to WHOQOL-BREF questionnaire. | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 
| Change in Total Impairment According to Schmeller et al. (2010) | Total impairment is measured by taking the mean of 7 numerical rating scales assessing the domains pain (spontaneous, pressure), swelling, hematoma, movement, cosmetic appearance and quality of life (0 (none) - 10 (always/very strong) points), see Schmeller et al. (2010). | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 
| Altered Depression Tendency According to PHQ-9 Questionnaire | Altered depression tendency according to PHQ-9 questionnaire (a clinically relevant improvement corresponds to ≥ 5 points reduction in PHQ-9 sum score). | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 
| Altered Hematoma Tendency According to Schmeller et al. (2010) | Hematoma (Are you prone to bruising?) is measured by a numerical rating scale (0 (none) - 10 (always/very strong) points), see Schmeller et al. (2010). | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 
| Changed Prevalence of Edema | Changed prevalence of edema | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 
| Change in the Scope of the Physical Therapy | The scope of the physical therapy is measured by the number of treatment sessions per month. | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 
| Change in Body Fat Percentage According to Wright et al. (1981) | Change in body fat percentage, determined according to formula from Wright et al. (1981), collected by means of measuring tape at the following points: abdominal circumference: measurement at the level of the navel. The tape measure is placed horizontally around the body neck circumference: measurement below the larynx body size hip circumference: the widest part of the hip is measured. | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 
| Change of Leg Circumference by Means of Measuring Tape | Change of leg circumference of the left and right leg by means of measuring tape at five specified measuring points: lower leg cuffs calf center knee 10 cm below the groin hips (iliac crest). | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 
| Movement Restriction Reduction According to LEFS Sum Score | Relevant reduction in movement restriction (stage I, II, or III; ≥ 9 points improvement in LEFS sum score) | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 
| Number of Recurrent Interventions | Number of recurrent interventions | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 
| Number of (Serious) Adverse Events | Number of (serious) adverse events | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 
| Number of Therapy Interruptions Caused by Adverse Events | Discontinuation of therapy caused by adverse events | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 
| Optional: Change of the Leg Volume by Means of Perometry | Optional: Change of the leg volume of the left and right leg (e.g. by means of perometry etc.) | 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipedema, complex decongestive therapy(CDT), liposuction