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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