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Table 1 Visit schedule—liposuction group

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

Liposuction group

 

Run-in phase

  

12 months of observation

24 months of follow-up

Visit

Screening Day 0

P1

≤4 wks

P2

6 mo. after P1

 

Lipo-suction(s) 1–4 mo. after P2

V1

6 mo.

V2

12 mo.

V3

6 mo.

V4

12 mo.

V5

18 mo.

V6

24 mo.

      

After completion of liposuctions(s)

After V2

Informed consent

x

  

Liposuction of the legs (2–4 surgeries at intervals of 5–7 weeks)

       

Information about liposuction

x

  

x

      

In-/exclusion criteria

x

 

x

       

Demographic data

x

         

Anamnesis

x

         

Concomitant medication

x

x

x

x

x

x

x

x

x

x

Weight

x

x

x

 

x

x

x

x

x

x

Leg circumference

x

x

x

 

x

x

x

x

x

x

Leg oedema

x

x

x

 

x

x

x

x

x

x

Body fat

x

x

x

 

x

x

x

x

x

x

Leg volume (optional)

x

x

x

 

x

x

x

x

x

x

Arm circumference

x

x

x

 

x

x

x

x

x

x

Skin appearance

x

x

x

 

x

x

x

x

x

x

Quality of life (SF-36, DLQI, WHOQOL-BREF)

x

x

x

 

x

x

x

x

x

x

Depression (PHQ-9)

x

x

x

 

x

x

x

x

x

x

Hematoma (mod. to Schmeller et al. 2010)

x

x

x

 

x

x

x

x

x

x

Overall impairment (mod. to Schmeller et al. 2010)

x

x

x

 

x

x

x

x

x

x

Pain (German Pain questionnaire)

x

x

x

 

x

x

x

x

x

x

Functional limitations (LEFS)

x

x

x

 

x

x

x

x

x

x

Randomisation

  

x

       

ECG

   

x

      

Laboratory data

   

x

      

Pregnancy test

X

 

x

x

      

Adverse events

 

x

x

x

x

x

x

x

x

x

Liposuction

   

x

      

Query on the necessity of recurrent liposuction

     

x

x

x

x

x

x

Query on the scope of CDT

x

x

x

 

x

x

x

x

x

x

x

  1. Abbreviations: wks weeks, mo months, SF-36 Short Form 36, DLQI Dermatology Life Quality Index, WHOQOL-BREF World Health Organization Quality of Life-abbreviated version of the WHOQOL 100, PHQ-9 Patient Health Questionnaire-9, LEFS Lower Extremity Functional Scale, CDT comprehensive decongestive therapy