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.
Female gender;
Treated for primary early stage breast cancer;
Early stage lymphedema of the arm (stage 1 or 2 on ISL classification);
ELV > 10%;
Male gender;
Stage 3 lymphedema of the arm;
Receiving current breast cancer treatment;
Distant breast cancer metastases;
Parallel
Lymphaticovenous anastomosis using Microsure Motion Stabilizer
DeviceThe 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.
Lymphaticovenous anastomosis (manual)
Procedure/SurgeryLymphaticovenous 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
Efficiency of lymphaticovenous anastomosis (LVA)
Efficiency of LVA is measured assessing the quality of the LVA using video recordings of the surgery, which is judged by two independent consultants. The Structured Assessment of Microsurgery Skills (SAMS) measuring method is used to assess the quality of each anastomosis. The SAMS score contains twelve separate items, scored from 1 (bad) to 5 (excellent), grouped into four areas (dexterity, visuo-spatial ability, operative flow and judgement), each subdivided into three technical components.
Duration of the surgery
The total duaton of the surgery is from the moment of exploration to find adequate lymph channels and venules to the time to finish the LVA anastomoses during surgery. It is hypothesised that robot assisted surgery will have an equal duration of surgery. The increased precision will compensate the initial extra time for settin up the robotic system
Errors during surgery
The SAMS list of peri-operative 'complications' (technical flaws) are judged by the two blinded consultants. The surgeon and research team will also register a list of peri-operative (technical) problems
Perioperative complications
The surgeon and research team will register a list of peri-operative complications, as well as complications during the full follow-up period.
Surgeon's satisfaction with the procedure
Is assessed using a ten point Visual Analogue Score. The higher the score, the higher the satisfaction of the surgeon.
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