RecruitingNot ApplicableNCT06082349

The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema

Effectiveness and Cost-effectiveness of Lymphaticovenous Anastomosis for Cancer Patients Who Suffer From Chronic Peripheral Lymphedema: a Randomized Controlled Trial


Sponsor

Maastricht University Medical Center

Enrollment

110 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Lymphaticovenous anastomosis and a procedure called Sham surgery for people with lymphedema arm, lymphedema of leg, and other related conditions. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELymphaticovenous 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

PROCEDURESham 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

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NCT06082349


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