Zusammenfassung (Niederländisch oder Französisch oder Englisch)
| Title |
Comparison of reconstructive surgery versus no surgery, additional to decongestive lymphatic therapy (usual care), for the treatment of lymphoedema, through a multicentre, pragmatic randomised controlled trial (SurLym-trial) |
|
Participants (P) |
Subjects with primary or secondary upper or lower limb lymphoedema stage 1 to 2b |
|
Intervention (I) |
Reconstructive surgery: LVA or LNT or combination, added to usual care |
|
Control (C) |
Usual care (no surgery) |
|
Outcome (O) |
Lymphoedema-specific QOL, at 18 months post-baseline |
|
Trial Design |
Multicentre, pragmatic randomised controlled trial |
|
Sample Size |
180 patients |
|
Trial duration |
48 months to CSR I with an additional 17 months to CSR II after FU |
|
Budget |
€1,800,000 |
|
Sponsor |
UZ Leuven |
|
Chief Investigator |
Prof. Nele Devoogdt |
|
Number of participating sites |
3 UZ Leuven, UZ Gent, CHU Mont Godinne |
|
External partner |
none |
| Protocol | View protocol PubMed |
| Results |
For timelines and recruitment, see dashboard
Clinicaltrials.gov: NCT05064176
Webpage:
2019 Investigator led
