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

Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis

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.

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.

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.