Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema
- Conditions
- Lymphedema ArmLymphoedema of LegLymphedema
- Interventions
- Other: Usual careProcedure: Reconstructive lymphatic surgery
- Registration Number
- NCT05064176
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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?'
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
-
Unilateral or bilateral, primary or secondary lymphoedema of the upper or lower limb
-
If cancer-related lymphoedema, approval for participation in study from oncological specialist (patient participation has to be discussed during Multidisciplinary Oncological Consult); approval if:
- 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
-
Objective diagnosis of lymphoedema: ≥ 5% volume difference OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of IndoCyanineGreen (ICG) dermal backflow
-
Score on Lymph-ICF questionnaire at screening: ≥ 25 / 100 (= moderate level of problems in functioning related to the development of lymphoedema)
-
History of at least 6 months of decongestive lymphatic therapy (DLT) until minimal pitting
-
Age ≥ 18 years
- 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)
- In case of lower limb lymphoedema: presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome
- Allergy for ICG, iodine, penicillin and sulphonamides; increased activity of thyroid gland; benign tumour in thyroid; heparin use and severe renal insufficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reconstructive lymphatic surgery Reconstructive lymphatic surgery 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) Reconstructive lymphatic surgery Usual care 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) No surgery Usual care All patients receive usual care (i.e. maintenance decongestive lymphatic therapy)
- Primary Outcome Measures
Name Time Method Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema) at 18 months evaluated with the Dutch or French version of the Lymph-ICF questionnaire for upper or lower limb lymphoedema
- Secondary Outcome Measures
Name Time Method Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema) at 1, 3, 6, 12 (short term) and 24, 36 (longer term) months evaluated with the Dutch or French version of the Lymph-ICF questionnaire for upper or lower limb lymphoedema
General health-related QoL at 1, 3, 6, 12, 18, 24, 36 months evaluated with the EuroQol-5D-5L questionnaire
Limb volume at 1, 3, 6, 12, 18 (key secondary outcome), 24, 36 months evaluated using circumference measures (ml)
Failure to reduce the hours a day of wearing the compression stocking at 12, 18, 24, 36 months failure is defined as not able to continue the reduction of the hours of wearing the compression garment as stated by the protocol
The hours of wearing the compression garment during one week at 12, 18 (key secondary outcome), 24, 36 months evaluated with the International Compression Club (ICC) questionnaire ('dosage score' between 0-168h)
The experience of the compression garment at 1, 3, 6, 12, 18, 24, 36 months evaluated with the International Compression Club (ICC) questionnaire ('comfort score' between 0-10 and 'complication score' between 0-10)
The physical activity level at 1, 3, 6, 12, 18, 24, 36 months evaluated with the International Physical Activity Questionnaire (IPAQ) - short form (MET-hours/week)
Body weight at 1, 3, 6, 12, 18, 24, 36 months measured using a balance
Complications of surgery at 1, 3, 6, 12, 18, 24, 36 months through interview
Recurrence of cancer (yes/no) at 36 months through medical file
Lymphatic transport at 18 months through lymphoscintigraphy
Costs related to lymphoedema and its treatment during previous 18 months at 18, 36 months through interview
The need for intensive treatment due to an increase in lymphoedema volume at 6, 12, 18, 24, 36 months through interview
Work capacity at 1, 3, 6, 12, 18, 24, 36 months evaluated with the Work Productivity and Activity Impairment (WPAI-GH) questionnaire
Work ability at 1, 3, 6, 12, 18, 24, 36 months evaluated with the Quickscan 18 (short form) questionnaire
Infection during the previous 18 months (yes/no) 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) through interview
Trial Locations
- Locations (3)
Ghent University Hospital
🇧🇪Gent, Belgium
University Hospitals of Leuven, center for lymphedema
🇧🇪Leuven, Belgium
CHU-UCL Mont-Godinne
🇧🇪Namur, Belgium