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The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema
Sponsor: Maastricht University Medical Center
Summary
The goal of this randomized controlled trial is to compare the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients suffering from unilateral cancer-related lymphedema in either the upper or lower extremity. It aims to answer whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score. A total of 110 participants will be allocated randomly into two groups at a 1:1 ratio. The first group will receive lymphaticovenous anastomosis (LVA), while the second group will undergo sham surgery.
Official title: Effectiveness and Cost-effectiveness of Lymphaticovenous Anastomosis for Cancer Patients Who Suffer From Chronic Peripheral Lymphedema: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2023-12-18
Completion Date
2029-03-01
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
Lymphaticovenous anastomosis
Lymphaticovenous anastomosis (LVA) involves connecting a lymphatic vessel to an adjacent vein of similar size, thereby facilitating the outflow of lymphatic fluid in patients suffering from secondary lymphedema
Sham surgery
Sham surgery involves the process of surgery, including local anesthesia and incisions, but no LVA is made.
Locations (3)
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands