RecruitingNot ApplicableNCT06532955

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

Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis

Sponsor

Maastricht University Medical Center

Enrollment

60 participants

Start Date

Jun 1, 2017

Study Type

INTERVENTIONAL

Conditions

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

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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 Criteria8

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.

Interventions

DEVICELymphaticovenous anastomosis using Microsure Motion Stabilizer

The robot-assisted LVA is performed using the Microsure Motion Stabilizer, a telemanipulation tool that stabilizes a surgeon's movement during open microsurgical operations on extremities, specifically on veins and nerves that are close to the skin. The surgeon controls a joystick, which directly copies the surgeon's movements in real-time to an instrument held by the device. The device's software scales down the motions and filters out tremor. Surgical technique and method of treatment are identical to conventional microsurgery. The device is equipped with genuine microsurgical instruments and is compatible with existing surgical microscopes. Instead of holding the instrument directly in hand, which is limited in precision and dexterity, the surgeon operates while the instrument's movements are stabilized. The modular design allows the surgeon to decide what level of manipulation assistance is required during a certain procedure.

PROCEDURELymphaticovenous anastomosis (manual)

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