Table 2.

Visit schedule—CDT group

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

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