RecruitingNot Applicable

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

Netherlands60 participantsStarted 2017-06-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Efficiency of lymphaticovenous anastomosis (LVA)

Timeframe: Assessed at one moment during, maximally up to 1 year postoperatively

Trial details

NCT IDNCT06532955

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

Contact for this trial

Alieske Kleeven, MSc

+31(0)433877481 alieske.kleeven@mumc.nl

View on ClinicalTrials.gov More Lymphedema trials