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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