Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema

NARecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

February 1, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2026

Conditions
Lymphoedema of LegLymphedema ArmLymphedema
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"

Trial Locations (3)

3000

RECRUITING

University Hospitals of Leuven, center for lymphedema, Leuven

Unknown

RECRUITING

Ghent University Hospital, Ghent

RECRUITING

CHU-UCL Mont-Godinne, Namur

All Listed Sponsors
lead

Universitaire Ziekenhuizen KU Leuven

OTHER