Actively Recruiting
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
180
Participants Needed
3
Research Sites
78 weeks
Total Duration
This research is investigating the added value of reconstructive lymphatic surgery in patients with upper or lower limb lymphoedema. The study compares this surgery combined with usual care, called decongestive lymphatic therapy, to usual care alone. The goal is to see if surgery improves lymphoedema-specific quality of life 18 months after treatment. Lymphoedema is a chronic condition causing limb swelling and physical and mental challenges, impacting daily function and work ability. Participants are randomly assigned to one of two groups: one group receives reconstructive lymphatic surgery, which may include lymphovenous anastomosis, lymph node transfer, or both, plus usual care. The other group receives usual care alone, consisting of maintenance decongestive lymphatic therapy including skin care, compression garments, exercises, and manual lymph drainage. Surgery choice is based on each patient's condition following a surgical algorithm. During the study, participants will undergo assessments at various time points up to 36 months. These include quality of life questionnaires, limb volume measurements, physical activity monitoring, work capacity evaluations, and tracking of compression garment use. Researchers will also monitor infections, surgery complications, lymphatic transport, and costs related to lymphoedema. The main outcome is quality of life related to lymphoedema at 18 months. Follow-up continues to evaluate longer-term effects and safety.
CONDITIONS
Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Single surgical procedure with post-operative recovery period
Participants assigned to the surgery group undergo reconstructive lymphatic surgery, which may include lymphovenous anastomosis, lymph node transfer, or both, in addition to usual care.
1 surgery visit plus follow-up visits as part of usual care
Duration - Up to 36 months with varying intensity: initial 6 months with physical therapy sessions, followed by maintenance and self-management
Participants receive maintenance decongestive lymphatic therapy including skin care, compression therapy, exercises, manual lymph drainage, and self-management education, continued throughout the study.
Weekly visits during initial months reducing to monthly and self-management visits over time
Duration - Up to 36 months
Participants are monitored for treatment effects, complications, and quality of life outcomes up to 36 months after enrollment.
Periodic assessments at 1, 3, 6, 12, 18, 24, and 36 months
Total: 3 locations
1
Ghent University Hospital
Ghent, Belgium
Actively Recruiting
2
University Hospitals of Leuven, center for lymphedema
Leuven, Belgium, 3000
Actively Recruiting
3
CHU-UCL Mont-Godinne
Namur, Belgium
Actively Recruiting
N
Nele Devoogdt
T
Tessa De Vrieze
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Nele Devoogdt, Tessa De Vrieze, An-Kathleen Heroes...
https://pubmed.ncbi.nlm.nih.gov/38729754