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 |