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RECRUITING
NCT06082349
NA

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

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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

PROCEDURE

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