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Table 2 Visit schedule—CDT group

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

CDT 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

V1

6 mo.

V2

12 mo.

 

optional:

Lipo-suction(s)

1-4 mo. after V2

V3

6 mo.

V4

12 mo.

V5

18 mo.

V6

24 mo.

    

After randomisation

  

After completion of liposuction(s) or V2

Informed consent

x

    

On demand of the patient: liposuction of the legs (2–4 surgeries at intervals of 5–7 weeks)

     

Information about OP

x

    

x

    

In-/exclusion criteria

x

 

x

 

x

     

Demographic data

x

         

Anamnesis

x

         

Weight

x

x

x

x

x

 

x

x

x

x

Concomitant medication

x

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

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