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Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema

ConditionsLymphoedema of LegLymphedema ArmLymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this 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?'

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Unilateral or bilateral, primary or secondary lymphoedema of the upper or lower limb

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Usual care

    Other intervention

    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 surgery

    Procedure/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: 1. Placed lymph nodes act as sponge to absorb lymphatic fluid and direct it into the vascular network; 2. Placed lymph nodes induce lymphangiogenesis

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Reconstructive lymphatic surgeryExperimental treatment 2 interventions
Group B: No surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

General health-related QoL

evaluated with the EuroQol-5D-5L questionnaire

Time frame
at 1, 3, 6, 12, 18, 24, 36 months
3

Limb volume

evaluated using circumference measures (ml)

Time frame
at 1, 3, 6, 12, 18 (key secondary outcome), 24, 36 months
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov
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