KCE-191245: Behandlung von Lymphödemen: Vergleich von rekonstruktiver Chirurgie versus keine Operation, zusätzlich zur Standardabschwellungstherapie. Eine pragmatische, multizentrische, randomisierte, kontrollierte Studie - SurLym

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

 

Trial Description
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 (€ 1,600,000 for study and € 200,000 for non-reimbursed surgery costs)

Status

Open

 

Trial team

Sponsor

UZ Leuven

Chief Investigator

Prof. Nele Devoogdt

Number of participating sites

3

UZ, Leuven, UZ Gent, CHU Mont Godinne

External partner

none

Documents
Protocol  
Report

Q3/2026

Publication

 

References

Clinicaltrials.gov: pending

Webpage: 

Funding scheme

2019 Investigator led