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The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema

RECRUITINGN/ASponsored by Maastricht University Medical Center
Actively Recruiting
PhaseN/A
SponsorMaastricht University Medical Center
Started2017-06-01
Est. completion2026-01-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06532955

Summary

This study assesses the performance of robot-assisted microsurgery. Lymphaticovenous anastomosis (LVA) is the most difficult procedure in microsurgery at this moment. The LVA technique is applied to treat for example breast cancer-related lymphedema (BCRL). Therefore, this LVA procedure is compared using a manual expert and the same expert applying robot-assisted LVA.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* Female gender;
* Treated for primary early stage breast cancer;
* Early stage lymphedema of the arm (stage 1 or 2 on ISL classification);
* ELV \> 10%;
* Suffering from unilateral disease.

Exclusion Criteria:

* Male gender;
* Stage 3 lymphedema of the arm;
* Receiving current breast cancer treatment;
* Distant breast cancer metastases;
* Current substance abuse;
* History of marcaine or indocyanine green allergy;
* Non-viable lymphatic system as determined by near infrared imaging;
* Previous LVA (\<10 years) in the arm with lymphedema.

Conditions11

Breast CancerCancerLymphedemaLymphedema ArmLymphedema of LimbLymphedema of Upper ArmLymphedema of Upper LimbLymphedema, Breast CancerLymphedema, Non-FilarialLymphedema, Secondary

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