An interventional study of Usual care and Reconstructive lymphatic surgery in Lymphoedema of Leg, Lymphedema Arm and Lymphedema, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 3 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment
The primary objective of this research proposal is to investigate
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?'
Lymphoedema is a chronic and often debilitating condition caused by lymphatic insufficiency. It leads to swelling of the limb and an increased risk of infection. It can be classified as primary (congenital) or secondary (acquired) lymphoedema.
Lymphoedema is very burdensome for the patient and therefore is it often associated with mental problems for example frustration and stress. In addition, because of the increase in volume of the limb, patients also develop physical problems, such as pain, heaviness, loss of strength, and develop functional problems, such as problems with household, mobility or social activities. These mental, physical and functional problems all have a negative impact on quality of life and have an influence on the ability to work. Consensus exist that the first choice of treatment is a conservative treatment. This conservative treatment consists of skin care, compression therapy (i.e. multilayer bandaging and compression garments), exercises and lymph drainage. Reconstructive lymphatic surgery is another option, also often performed: i.e. lymphovenous anastomoses, on the one hand, and a lymph node transfer, on the other hand. By (partially) restoring the lymphatic transport, the reconstructive lymphatic surgery may possibly lead to a larger decrease of the lymphoedema volume and therefore greater discontinuation of the compression garment. Consequently, patients will have an improvement in functioning and quality of life.
Currently, scientific evidence for reconstructive lymphatic surgery for the treatment of lymphoedema is missing. Therefore, the aim of this trial is to investigate the added value of reconstructive lymphatic surgery of the lymphatic system in addition to the conservative treatment, for the treatment of lymphoedema.
560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.
This study's planned enrollment of 180 is above the median of 50 across 403 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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If cancer-related lymphoedema, approval for participation in study from oncological specialist (patient participation has to be discussed during Multidisciplinary Oncological Consult); approval if:
Exclusion Criteria:
The intervention treatment is reconstructive lymphatic surgery and consists of the application of lymphovenous anastomosis (LVA), lymph node transfer (LNT) or a combination of both. The choice of reconstructive technique(s) is determined by the surgeon and is based on the algorithm for reconstructive lymphatic surgery of lymphoedema. Additionally, all patients receive usual care (i.e. maintenance decongestive lymphatic therapy)
Other: Usual care · Procedure: Reconstructive lymphatic surgery
All patients receive usual care (i.e. maintenance decongestive lymphatic therapy)
Other: Usual care
Home physical therapist performs usual care and educates the patient to perform self-management Usual care: M1-6: 6 months of maintenance decongestive lymphatic therapy (DLT) (by patient and home physical therapist): * week 1-2: no physical therapy; patient performs limb elevation, muscle contractions and wears the bandage (intervention group)/ compression garment (control group) * week 3-4: start physical therapy, 2 days/ week: exercises, skin care \& manual lymph drainage (MLD), education; self-management by patient and wearing compression garment 14-16h/day (4 sessions) M2-6: 1 day/ week physical therapist: exercises, skin care \& MLD, and self-management by patient and wearing compression garment 14-16h/day (20 sessions) M7-12: 6 months of maintenance DLT by patient (self-management) and home physical therapist: - 1 day/week physical therapist: skin care, MLD, exercises (26 sessions) Month 13-18: 6 months of maintenance DLT by patient Month 19-36: 18 months of follow-up
For the procedure of LVA: - Aim: making anastomoses of lymph vessels at the capillary level with a diameter of 0.3 to 0.8 mm, to redirect lymph to venous stream directly For the procedure of LNT: - Aim: 1. Placed lymph nodes act as sponge to absorb lymphatic fluid and direct it into the vascular network; 2. Placed lymph nodes induce lymphangiogenesis
Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)
evaluated with the Dutch or French version of the Lymph-ICF questionnaire for upper or lower limb lymphoedema
Time frame: at 18 months
Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)
evaluated with the Dutch or French version of the Lymph-ICF questionnaire for upper or lower limb lymphoedema
Time frame: at 1, 3, 6, 12 (short term) and 24, 36 (longer term) months
General health-related QoL
evaluated with the EuroQol-5D-5L questionnaire
Time frame: at 1, 3, 6, 12, 18, 24, 36 months
Limb volume
evaluated using circumference measures (ml)
Time frame: at 1, 3, 6, 12, 18 (key secondary outcome), 24, 36 months
Failure to reduce the hours a day of wearing the compression stocking
failure is defined as not able to continue the reduction of the hours of wearing the compression garment as stated by the protocol
Time frame: at 12, 18, 24, 36 months
The hours of wearing the compression garment during one week
evaluated with the International Compression Club (ICC) questionnaire ('dosage score' between 0-168h)
Time frame: at 12, 18 (key secondary outcome), 24, 36 months
The experience of the compression garment
evaluated with the International Compression Club (ICC) questionnaire ('comfort score' between 0-10 and 'complication score' between 0-10)
Time frame: at 1, 3, 6, 12, 18, 24, 36 months
The physical activity level
evaluated with the International Physical Activity Questionnaire (IPAQ) - short form (MET-hours/week)
Time frame: at 1, 3, 6, 12, 18, 24, 36 months
The need for intensive treatment due to an increase in lymphoedema volume
through interview
Time frame: at 6, 12, 18, 24, 36 months
Body weight
measured using a balance
Time frame: at 1, 3, 6, 12, 18, 24, 36 months
Work capacity
evaluated with the Work Productivity and Activity Impairment (WPAI-GH) questionnaire
Time frame: at 1, 3, 6, 12, 18, 24, 36 months
Work ability
evaluated with the Quickscan 18 (short form) questionnaire
Time frame: at 1, 3, 6, 12, 18, 24, 36 months
Infection during the previous 18 months (yes/no)
through interview
Time frame: at 18, 36 months (adverse events are collected during each clinical assessment but the amount of infections as secondary outcome are taken together for statistical analyses per 18 months)
Complications of surgery
through interview
Time frame: at 1, 3, 6, 12, 18, 24, 36 months
Recurrence of cancer (yes/no)
through medical file
Time frame: at 36 months
Lymphatic transport
through lymphoscintigraphy
Time frame: at 18 months
Costs related to lymphoedema and its treatment during previous 18 months
through interview
Time frame: at 18, 36 months
Plan to share: Yes — Individual Participant Data (IPD) can be shared upon request.
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Universitaire Ziekenhuizen KU Leuven