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| Name | Class |
|---|---|
| The Clinical Trials Centre Cologne | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | 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. |
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| Control group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposuction | Procedure | 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. |
| 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) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
Lipedema is a symmetrical, congenital, excessive increase in fatty tissue on the legs, which occurs almost exclusively in women.
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| Name | Affiliation | Role |
|---|---|---|
| Maurizio Podda, Dr. med. | Hautklink Darmstadt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis für Dermatologie, Dermatochirurgie und Phlebologie | Freiburg im Breisgau | Baden-Wurttemberg | 79098 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34717741 | Derived | 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. |
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After a run in phase, randomization is performed in the intervention and control arm (2:1).
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Random assignment of patients to one of the two treatment groups (experimental or controlled) is provided centrally via a 24/7 Internet service in ratio 2:1 (experimental: controlled) based on permuted blocks. The assignment is stratified to stage and centre.
| 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:
| 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:
| 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) |
| Venenzentrum Freiburg |
| Freiburg im Breisgau |
| Baden-Wurttemberg |
| 79108 |
| Germany |
| Universitätsklinikum Regensburg | Regensburg | Bavaria | 93053 | Germany |
| Klinikum Ernst von Bergmann | Potsdam | Brandenburg | 14467 | Germany |
| Hautmedizin Bad Soden | Bad Soden am Taunus | Hesse | 65812 | Germany |
| Hautklinik Darmstadt | Darmstadt | Hesse | 64283 | Germany |
| Hautarztpraxis Mühltal | Mühltal | Hesse | 64367 | Germany |
| Evangelisches Krankenhaus Oldenburg Klinik für Plastische, Ästhetische, Rekonstruktive und Handchirurgie | Oldenburg | Lower Saxony | 26122 | Germany |
| Johanniter GmbH Waldkrankenhaus Bonn | Bonn | North Rhine-Westphalia | 53177 | Germany |
| Klinik und Praxisklinik für Plastische Chirurgie | Cologne | North Rhine-Westphalia | 50668 | Germany |
| MVZ Praxis | Cologne | North Rhine-Westphalia | 51069 | Germany |
| MVZ Praxis Dr. Cornely Düsseldorf MVZ Corius Nordrhein GmbH | Düsseldorf | North Rhine-Westphalia | 40474 | Germany |
| ID | Term |
|---|---|
| D065134 | Lipedema |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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