Clinical trial NCT04272827: Evaluation Between Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy (CDT) Alone
Official title: Multicentre, Controlled, Randomized, Investigator-blinded Clinical Trial on Efficacy and Safety of Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy Alone (LIPLEG)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lipedema
Keywords: Lipedema
complex decongestive therapy(CDT)
liposuction
Lead sponsor: Hautklinik Darmstadt
Sponsor class: OTHER
Collaborators: name: The Clinical Trials Centre Cologne
First posted: 2020-02-17
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After a run in phase, randomization is performed in the intervention and control arm (2:1).
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful Pain Reduction After 12 Months (≥ 2 Points on a Numeric Rating Scale)
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary outcomes:
measure: Change in Pain Severity as Assessed by German Pain Questionnaire
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomization (control group) compared with the time of randomisation)
measure: Change in Health-Related Quality of Life According to SF-36 Questionnaire
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomization (control group) compared with the time of randomisation)
measure: Change in Health-Related Quality of Life According to DLQI Questionnaire
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
measure: Change in Health-Related Quality of Life According to WHOQOL-BREF Questionnaire
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
measure: Change in Total Impairment According to Schmeller et al. (2010)
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
measure: Altered Depression Tendency According to PHQ-9 Questionnaire
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
measure: Altered Hematoma Tendency According to Schmeller et al. (2010)
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
measure: Changed Prevalence of Edema
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
measure: Change in the Scope of the Physical Therapy
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
measure: Change in Body Fat Percentage According to Wright et al. (1981)
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
measure: Change of Leg Circumference by Means of Measuring Tape
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
measure: Movement Restriction Reduction According to LEFS Sum Score
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
measure: Number of Recurrent Interventions
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
measure: Number of (Serious) Adverse Events
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
measure: Number of Therapy Interruptions Caused by Adverse Events
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
measure: Optional: Change of the Leg Volume by Means of Perometry
timeFrame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Praxis für Dermatologie, Dermatochirurgie und Phlebologie
state: Baden-Württemberg
city: Freiburg
country: Germany
facility: Venenzentrum Freiburg
state: Baden-Württemberg
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
state: Bavaria
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann
state: Brandenburg
city: Bad Soden am Taunus
country: Germany
facility: Hautmedizin Bad Soden
state: Hessen
city: Darmstadt
country: Germany
facility: Hautklinik Darmstadt
state: Hessen
city: Mühltal
country: Germany
facility: Hautarztpraxis Mühltal
state: Hessen
city: Oldenburg
country: Germany
facility: Evangelisches Krankenhaus Oldenburg Klinik für Plastische, Ästhetische, Rekonstruktive und Handchirurgie
state: Lower Saxony
city: Bonn
country: Germany
facility: Johanniter GmbH Waldkrankenhaus Bonn
state: North Rhine-Westphalia
city: Cologne
country: Germany
facility: Klinik und Praxisklinik für Plastische Chirurgie
state: North Rhine-Westphalia
city: Cologne
country: Germany
facility: MVZ Praxis
state: North Rhine-Westphalia
city: Düsseldorf
country: Germany
facility: MVZ Praxis Dr. Cornely Düsseldorf MVZ Corius Nordrhein GmbH
state: NRW
Study officials:
affiliation: Hautklink Darmstadt
name: Maurizio Podda, Dr. med.
role: STUDY_CHAIR
References:
citation: Podda M, Kovacs M, Hellmich M, Roth R, Zarrouk M, Kraus D, Prinz-Langenohl R, Cornely OA. A randomised controlled multicentre investigator-blinded clinical trial comparing efficacy and safety of surgery versus complex physical decongestive therapy for lipedema (LIPLEG). Trials. 2021 Oct 30;22(1):758. doi: 10.1186/s13063-021-05727-2.