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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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.

Description

Microsurgery facilitates procedures such as transplantation of tissue as well as lymphedema treatment. Currently, the plastic surgeon's hands are the limiting factor in microsurgical performance. Robot-assistence increases the movement in precision and might therefore be of great importance for the advancement of microsurgery in the world.

It is a prospective study in Maastricht University Medical Center assessing 60 patients undergoing either robot-assisted or manual lymphaticovenous anastomosis (LVA) tot treat breast cancer-related lymphedema (BCRL). The primary outcome parameter is LVA technique. Secondary outcome measures include duration of surgery, technical errors during & complications peri-operatively, surgeon's satisfaction with the LVA procedure, teh patients' convenience during surgery, arm volume over time and patient's symptoms development over time.

Eligibility

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.

Study details
    Lymphedema
    Lymphedema Arm
    Lymphedema of Upper Arm
    Lymphedema of Upper Limb
    Lymphedema; Surgical
    Lymphedema
    Secondary
    Lymphedema of Limb
    Lymphedema
    Breast Cancer
    Lymphedema
    Non-Filarial

NCT06532955

Maastricht University Medical Center

15 October 2025

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