Evidence map›Paper›PMID 34717741›Full record

Trial reportTrials2021

A randomised controlled multicentre investigator-blinded clinical trial comparing efficacy and safety of surgery versus complex physical decongestive therapy for lipedema (LIPLEG).

Maurizio Podda, Maximilian Kovacs, Martin Hellmich, Rebecca Roth, Marouan Zarrouk, Daria Kraus, Reinhild Prinz-Langenohl, Oliver A Cornely

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04272827 (Multicentre, Controlled, Randomized, Investigator-blinded Clinical Trial on Efficacy and Safety of Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy Alone), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04272827 naactive not recruitingnot on this map

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

TypeinterventionalSponsorHautklinik DarmstadtRan2021 to 2026Enrolled450ConditionsLipedemaArmsLiposuction
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
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  3. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Maurizio PoddaDepartment of Dermatology, Medical Center Klinikum Darmstadt, Teaching Hospital Goethe-University Frankfurt, Grafenstr. 9, 64283, Darmstadt, Germany. maurizio.podda@mail.klinikum-darmstadt.de.ORCID http://orcid.org/0000-0002-1442-1223
Maximilian KovacsDepartment of Dermatology, Medical Center Klinikum Darmstadt, Teaching Hospital Goethe-University Frankfurt, Grafenstr. 9, 64283, Darmstadt, Germany.
Martin HellmichUniversity of Cologne, Institute of Medical Statistics and Computational Biology, Faculty of Medicine and University Hospital Cologne, Robert-Koch-Str. 10, 50924, Cologne, Germany.
Rebecca RothUniversity of Cologne, Institute of Medical Statistics and Computational Biology, Faculty of Medicine and University Hospital Cologne, Robert-Koch-Str. 10, 50924, Cologne, Germany.
Marouan ZarroukClinical Trials Centre Cologne (ZKS Köln), Faculty of Medicine and University Hospital Cologne, University of Cologne, Gleueler Str. 269, 50935, Cologne, Germany.
Daria KrausClinical Trials Centre Cologne (ZKS Köln), Faculty of Medicine and University Hospital Cologne, University of Cologne, Gleueler Str. 269, 50935, Cologne, Germany.
Reinhild Prinz-LangenohlClinical Trials Centre Cologne (ZKS Köln), Faculty of Medicine and University Hospital Cologne, University of Cologne, Gleueler Str. 269, 50935, Cologne, Germany.
Oliver A CornelyClinical Trials Centre Cologne (ZKS Köln), Faculty of Medicine and University Hospital Cologne, University of Cologne, Gleueler Str. 269, 50935, Cologne, Germany.
University of Cologne · DEGoethe University Frankfurt · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLipedema is a chronic disorder of the adipose tissue that affects mainly women, characterised by symmetrical, excessive fatty tissue on the legs and pain. Standard conservative treatment is long-term comprehensive decongestive therapy (CDT) to alleviate lipedema-related pain and to improve psychosocial well-being, mobility and physical activity. Patients may benefit from surgical removal of abnormally propagated adipose tissue by liposuction. The LIPLEG trial evaluates the efficacy and safety of liposuction compared to standard CDT. METHODS/

designLIPLEG is a randomised controlled multicentre investigator-blinded trial. Women with lipedema (n=405) without previous liposuction will be allocated 2:1 to liposuction or CDT. The primary outcome of the trial is leg pain reduction by ≥2 points on a visual analogue scale ranging 0-10 at 12 months on CDT or post-completion of liposuction. Secondary outcomes include changes in leg pain severity, health-related quality of life, depression tendency, haematoma tendency, prevalence of oedema, modification physical therapy scope, body fat percentage, leg circumference and movement restriction. The primary analysis bases on intention-to-treat. Success proportions are compared using the Mantel-Haenszel test stratified by lipedema stage at a 5% two-sided significance level. If this test is statistically significant, the equality of the response proportions in the separate strata is evaluated by Fisher's exact test in a hierarchical test strategy. DISCUSSION: LIPLEG assesses whether surgical treatment of lipedema is safe and effective to reduce pain and other lipedema-related health issues. The findings of this trial have the potential to change the standard of care in lipedema.

trial registrationClinicalTrials.gov NCT04272827. Registered on February 14, 2020. TRIAL STATUS: Protocol version is 02_0, December 17, 2019.

Indexed as

LipectomyLipedemaEdemaExerciseFemaleHumansQuality of LifeTreatment OutcomeComplex decongestive therapyLipedemaLiposuctionPhase 3Randomisation

Identifiers

PMID34717741
PMCPMC8557553
OpenAlexW3208227648

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.