Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT05064176
Status
Recruiting
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Conditions

  • Lymphedema
  • Lymphedema Arm
  • Lymphoedema of Leg

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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): * 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
    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

Study Details

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?'

Key Dates

First listed
Oct 1, 2021
Start date
Feb 1, 2022
Status verified
Jul 2024
Primary completion
Jun 30, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)
  • Active Comparator: No surgery
    All patients receive usual care (i.e. maintenance decongestive lymphatic therapy)

Primary Outcome Measure

Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema) [ Time Frame: at 18 months ]

Central Contacts

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