Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema

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 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?'

Conditions

• Lymphoedema of Leg
• Lymphedema Arm
• Lymphedema

Interventions

OTHER

Usual care

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

PROCEDURE

Reconstructive lymphatic 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Nele Devoogdt · Universitaire Ziekenhuizen KU Leuven

• Thierry Deltombe · CHU-UCL Mont-Godinne

• Caren Randon · University Hospital, Ghent

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-01

Primary Completion

2025-06-30

Completion

2026-12-31

Countries

• Belgium

Study Locations