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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reconstructive lymphatic surgery | Experimental | 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 | Active Comparator | All patients receive usual care (i.e. maintenance decongestive lymphatic therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Other | 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):
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 1, 3, 6, 12 (short term) and 24, 36 (longer term) months |
| General health-related QoL |
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Inclusion Criteria:
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:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nele Devoogdt | Contact | 0032 16 34 25 15 | nele.devoogdt@kuleuven.be | |
| Tessa De Vrieze | Contact | 0032 16 34 50 06 | tessa.devrieze@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Nele Devoogdt | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Thierry Deltombe | CHU-UCL Mont-Godinne | Principal Investigator |
| Caren Randon |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Recruiting | Ghent | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38729754 | Derived | Devoogdt N, De Vrieze T, Heroes AK, Bechter-Hugl B, Fieuws S, Godderis L, Segers K, Maleux G, Deltombe T, Frippiat J, Servaes M, Berners A, Fosseprez P, Krug B, Kayser F, Falticeanu A, Randon C, Monten C, Van Landuyt K, De Pypere B, Degraeve L, Decorte T, De Schryver M, Van Besien V, Devos D, Suominen S, Ayala JM, Pons G, Fourneau I, Thomis S. SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema. BMJ Open. 2024 May 10;14(5):e078114. doi: 10.1136/bmjopen-2023-078114. |
| Label | URL |
|---|---|
| Belgium Health Care Knowledge Centre (KCE) | View source |
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Individual Participant Data (IPD) can be shared upon request.
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Given the nature of the trial, blinding of participants, the person who performs the trial assessments (= investigator) and care providers (surgeon/ physical therapist/ compression specialist) is not feasible.
The person who will be performing data analyses (= outcome assessor) will be blinded to the participants' randomization.
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| Reconstructive lymphatic surgery | Procedure | 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:
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evaluated with the EuroQol-5D-5L questionnaire |
| at 1, 3, 6, 12, 18, 24, 36 months |
| Limb volume | evaluated using circumference measures (ml) | 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 | 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) | 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) | 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) | at 1, 3, 6, 12, 18, 24, 36 months |
| The need for intensive treatment due to an increase in lymphoedema volume | through interview | at 6, 12, 18, 24, 36 months |
| Body weight | measured using a balance | at 1, 3, 6, 12, 18, 24, 36 months |
| Work capacity | evaluated with the Work Productivity and Activity Impairment (WPAI-GH) questionnaire | at 1, 3, 6, 12, 18, 24, 36 months |
| Work ability | evaluated with the Quickscan 18 (short form) questionnaire | at 1, 3, 6, 12, 18, 24, 36 months |
| Infection during the previous 18 months (yes/no) | through interview | 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 | at 1, 3, 6, 12, 18, 24, 36 months |
| Recurrence of cancer (yes/no) | through medical file | at 36 months |
| Lymphatic transport | through lymphoscintigraphy | at 18 months |
| Costs related to lymphoedema and its treatment during previous 18 months | through interview | at 18, 36 months |
| University Hospital, Ghent |
| Principal Investigator |
| University Hospitals of Leuven, center for lymphedema | Recruiting | Leuven | 3000 | Belgium |
|
| CHU-UCL Mont-Godinne | Recruiting | Namur | Belgium |
|
| Improving Care for Edema and Oncology patients (CarEdOn) | View source |