Lymphoedema of LegSurLymNCT05064176
Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema
A study testing Reconstructive lymphatic surgery in people with Lymphoedema of Leg and Lymphedema Arm, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoedema of Leg, Lymphedema Arm, Lymphedema
- What is being tested?
- Reconstructive lymphatic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Feb 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites, 3 recruiting
- Recruiting
Ghent University Hospital
Ghent
Caren Randon, PhD, Caren.randon@uzgent.be
0032 9 332 34 49
- Recruiting
University Hospitals of Leuven, center for lymphedema
Leuven, 3000
Nele Devoogdt, PhD, 0032 16 342515, nele.devoogdt@uzleuven.be
Tessa De Vrieze, PhD, 0032 16 34 50 06, tessa.devrieze@kuleuven.be
- Recruiting
CHU-UCL Mont-Godinne
Namur
Thierry Deltombe, PhD, Thierry.deltombe@uclouvain.be
0032 81 42 37 72
About this study
Official title: 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?'
Read the 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.
- Conditions
- Lymphoedema of Leg, Lymphedema Arm, Lymphedema
- Being tested
- Usual care, Reconstructive lymphatic surgery
- Keywords
- Reconstructive lymphatic surgery, Decongestive lymphatic therapy, Lymphovenous anastomosis, Lymph node transfer
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
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
Reconstructive lymphatic surgeryProcedure or surgery
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:
- Placed lymph nodes act as sponge to absorb lymphatic fluid and direct it into the vascular network;
- Placed lymph nodes induce lymphangiogenesis
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Usual care; Procedure: Reconstructive lymphatic surgery |
| No surgery | Active comparator | All patients receive usual care (i.e. maintenance decongestive lymphatic therapy) Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 18 months
Secondary outcomes (16)
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
Measured: at 1, 3, 6, 12 (short term) and 24, 36 (longer term) months
General health-related QoL
evaluated with the EuroQol-5D-5L questionnaire
Measured: at 1, 3, 6, 12, 18, 24, 36 months
Limb volume
evaluated using circumference measures (ml)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at 1, 3, 6, 12, 18, 24, 36 months
The need for intensive treatment due to an increase in lymphoedema volume
through interview
Measured: at 6, 12, 18, 24, 36 months
Body weight
measured using a balance
Measured: at 1, 3, 6, 12, 18, 24, 36 months
Work capacity
evaluated with the Work Productivity and Activity Impairment (WPAI-GH) questionnaire
Measured: at 1, 3, 6, 12, 18, 24, 36 months
Work ability
evaluated with the Quickscan 18 (short form) questionnaire
Measured: at 1, 3, 6, 12, 18, 24, 36 months
Infection during the previous 18 months (yes/no)
through interview
Measured: 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
Measured: at 1, 3, 6, 12, 18, 24, 36 months
Recurrence of cancer (yes/no)
through medical file
Measured: at 36 months
Lymphatic transport
through lymphoscintigraphy
Measured: at 18 months
Costs related to lymphoedema and its treatment during previous 18 months
through interview
Measured: at 18, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Feb 2022
- Primary completionJun 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoedema of LegStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nele Devoogdt, Principal investigator, Universitaire Ziekenhuizen KU LeuvenThierry Deltombe, Principal investigator, CHU-UCL Mont-GodinneCaren Randon, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064176
- Sponsor's protocol ID
- KCE19-1245
- Acronym
- SurLym
- Status last verified
- Jul 2024
- First submitted
- 24 Aug 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) can be shared upon request.
Publications
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.
PubMed 38729754
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05064176
- Acronym / sponsor ID
- SurLym / KCE19-1245
- Conditions
- Lymphoedema of Leg, Lymphedema Arm, Lymphedema
- Keywords
- Reconstructive lymphatic surgery, Decongestive lymphatic therapy, Lymphovenous anastomosis, Lymph node transfer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reconstructive lymphatic surgery | Experimental | Other: Usual care, Procedure: Reconstructive lymphatic surgeryThe 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 | Other: Usual careAll patients receive usual care (i.e. maintenance decongestive lymphatic therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careHome 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 | Other | No surgery, Reconstructive lymphatic surgery |
| Reconstructive lymphatic surgeryFor 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 | Procedure or surgery | Reconstructive lymphatic surgery |
Primary outcome
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
16 secondary outcomes
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
General health-related QoL
Time frame: 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
Failure to reduce the hours a day of wearing the compression stocking
Time frame: 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
The experience of the compression garment
Time frame: at 1, 3, 6, 12, 18, 24, 36 months
The physical activity level
Time frame: 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
Body weight
Time frame: at 1, 3, 6, 12, 18, 24, 36 months
Work capacity
Time frame: at 1, 3, 6, 12, 18, 24, 36 months
Work ability
Time frame: 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)
Complications of surgery
Time frame: at 1, 3, 6, 12, 18, 24, 36 months
Recurrence of cancer (yes/no)
Time frame: at 36 months
Lymphatic transport
Time frame: at 18 months
Costs related to lymphoedema and its treatment during previous 18 months
Time frame: at 18, 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 38729754Devoogdt 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.
- Belgium Health Care Knowledge Centre (KCE)Link provided by the sponsor.
- Improving Care for Edema and Oncology patients (CarEdOn)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) can be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nele Devoogdt principal investigator
Universitaire Ziekenhuizen KU Leuven
Thierry Deltombe principal investigator
CHU-UCL Mont-Godinne
Caren Randon principal investigator
University Hospital, Ghent
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconstructive lymphatic surgery in people with Lymphoedema of Leg and Lymphedema Arm, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nele Devoogdt (0032 16 34 25 15, nele.devoogdt@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema) (time frame: at 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05064176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.