Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
The primary objective of this research proposal is to investigate
* in patients with lymphoedema of the upper limb or lower limb (P) * the added value of reconstructive lymphatic surgery (I) * to the decongestive lymphatic therapy (usual care) (C) * on the lymphoedema-specific quality of life (QoL) (O) * at 18 months post-surgery/ no surgery (T)
Consequently, a multicentre pragmatic randomised controlled trial is performed to give an answer on following research question: 'Is, in addition to usual care - i.e. decongestive lymphatic therapy -, reconstructive lymphatic surgery (intervention group) superior to no surgery (control group), for the treatment of upper or lower limb lymphoedema?'
Eligibility criteria
Qualifiers
Unilateral or bilateral, primary or secondary lymphoedema of the upper or lower limb
estimated cancer-related survival is ≥3 years
oncological safety is guaranteed: for instance, time interval since radiotherapy/ chemotherapy is ≥3 months
Lymphoedema stage 1 to 2b
Disqualifiers
Participants with history of liposuction, lymphovenous anastomosis, lymph node transfer
Pregnant participants
Severe obese participants: BMI>35
Estimated cancer-related survival is <3 years and oncological safety is not guaranteed (e.g. interval since radiotherapy/ chemotherapy is <3 months)
Trial design
Treatments tested in this trial
- Usual care
- Reconstructive lymphatic surgery
Treatment groups
180 Participants
are divided into 2 treatment groupsLocations
3Ghent University Hospital Ghent Belgium
University Hospitals of Leuven, center for lymphedema3000, Leuven Belgium
CHU-UCL Mont-Godinne Namur Belgium
Sponsors and collaborators
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Source ClinicalTrials.gov