- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05064176
Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema (SurLym)
Comparison of Reconstructive Lymphatic Surgery Versus no Surgery, Additional to Decongestive Lymphatic Therapy (Usual Care), for the Treatment of Iymphoedema, Through a Multicentre Randomised Controlled 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?'
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nele Devoogdt
- Phone Number: 0032 16 34 25 15
- Email: nele.devoogdt@kuleuven.be
Study Contact Backup
- Name: Tessa De Vrieze
- Phone Number: 0032 16 34 50 06
- Email: tessa.devrieze@kuleuven.be
Study Locations
-
-
-
Gent, Belgium
- Recruiting
- Ghent University Hospital
-
Contact:
- Caren Randon, PhD
- Email: Caren.randon@uzgent.be
-
Contact:
- Phone Number: 0032 9 332 34 49
-
Leuven, Belgium, 3000
- Recruiting
- University Hospitals of Leuven, center for lymphedema
-
Namur, Belgium
- Recruiting
- CHU-UCL Mont-Godinne
-
Contact:
- Thierry Deltombe, PhD
- Email: Thierry.deltombe@uclouvain.be
-
Contact:
- Phone Number: 0032 81 42 37 72
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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) |
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 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:
|
Active Comparator: No surgery
All patients receive usual care (i.e.
maintenance decongestive lymphatic therapy)
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)
Time Frame: at 18 months
|
evaluated with the Dutch or French version of the Lymph-ICF questionnaire for upper or lower limb lymphoedema
|
at 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)
Time Frame: 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
|
at 1, 3, 6, 12 (short term) and 24, 36 (longer term) months
|
General health-related QoL
Time Frame: at 1, 3, 6, 12, 18, 24, 36 months
|
evaluated with the EuroQol-5D-5L questionnaire
|
at 1, 3, 6, 12, 18, 24, 36 months
|
Limb volume
Time Frame: at 1, 3, 6, 12, 18 (key secondary outcome), 24, 36 months
|
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
Time Frame: 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
|
at 12, 18, 24, 36 months
|
The hours of wearing the compression garment during one week
Time Frame: at 12, 18 (key secondary outcome), 24, 36 months
|
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
Time Frame: 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)
|
at 1, 3, 6, 12, 18, 24, 36 months
|
The physical activity level
Time Frame: at 1, 3, 6, 12, 18, 24, 36 months
|
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
Time Frame: at 6, 12, 18, 24, 36 months
|
through interview
|
at 6, 12, 18, 24, 36 months
|
Body weight
Time Frame: at 1, 3, 6, 12, 18, 24, 36 months
|
measured using a balance
|
at 1, 3, 6, 12, 18, 24, 36 months
|
Work capacity
Time Frame: at 1, 3, 6, 12, 18, 24, 36 months
|
evaluated with the Work Productivity and Activity Impairment (WPAI-GH) questionnaire
|
at 1, 3, 6, 12, 18, 24, 36 months
|
Work ability
Time Frame: at 1, 3, 6, 12, 18, 24, 36 months
|
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)
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)
|
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
Time Frame: at 1, 3, 6, 12, 18, 24, 36 months
|
through interview
|
at 1, 3, 6, 12, 18, 24, 36 months
|
Recurrence of cancer (yes/no)
Time Frame: at 36 months
|
through medical file
|
at 36 months
|
Lymphatic transport
Time Frame: at 18 months
|
through lymphoscintigraphy
|
at 18 months
|
Costs related to lymphoedema and its treatment during previous 18 months
Time Frame: at 18, 36 months
|
through interview
|
at 18, 36 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nele Devoogdt, Universitaire Ziekenhuizen KU Leuven
- Principal Investigator: Thierry Deltombe, CHU-UCL Mont-Godinne
- Principal Investigator: Caren Randon, University Hospital, Ghent
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCE19-1245
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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