Lymphedema, Lymphedema Arm, Lymphedema, Breast Cancer, Lymphedema, Non-Filarial, Lymphedema of Limb, Lymphedema of Upper Arm, Lymphedema of Upper Limb, Lymphedema, Secondary, Lymphedema; Surgical
Conditions
Keywords
Robot-assisted microsurgery, Microsurgery, Robot, Robotic-assisted, Robot-assisted, Lymphaticovenous anastomosis, Lymphatico-venular anastomosis, LVA
Brief 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.
Detailed 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.
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
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency of lymphaticovenous anastomosis (LVA) | Assessed at one moment during, maximally up to 1 year postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Errors during surgery | Assessed during surgery and registered directly after the surgery on the same day as the 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 | Assessed during surgery and postoperatively, in case any occur | 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 | Assessed directly after surgery, on the same day as the surgery | Is assessed using a ten point Visual Analogue Score. The higher the score, the higher the satisfaction of the surgeon. |
| Surgeon's learning curve with the procedure in practise | Assessed through study completion, an average of 1 year | To study the learning curve will be calculated by using a curve fitting method to model learning curves. |
| Duration of the surgery | Assessed once and registered directly after 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 |
| Arm circumference over time | At baseline, 3, 6, and 12 months following LVA | Arm circumference is assessed by measuring both arms using the Upper Extremity Lymphedema (UEL) index. The arm is measured at 10 and 5 centimeters above and below the elbow, at the elbow, wrist and dorsum of the hand. |
| Arm volume over time | At baseline, 3, 6, and 12 months following LVA | Water volumetry assess the arm volume over time |
| Patient's symptoms over time | At baseline, 3, 6 and 12 months following LVA | The Lymphoedema Functioning, Disability and Health (Lymph-ICF) questionnaire assesses physical function, mental function, household activities, mobility activities, and life and social activities. This questionnaire is filled in to evaluate the effect of the LVA surgery and is part of the general evaluation of LVA patients. The questionnaire takes approximately five minutes and consists of 29 questions. The score ranges from 0 to 100, with 0 being the highest healthrelated quality of life. |
| Patient's convenience during the surgery | Assessed directly postoperatively,on the same day as the surgery | Patients' overall convenience during the surgery is assessed using a ten point Visual Analogye Score. The higher the score, the more the patient had experienced during surgery. Moreover, patients are asked to fill in if peculiar matters had occurred which might help to increase the patients overall experience during surgery. |
Countries
Netherlands
Contacts
Primary ContactAlieske Kleeven, MSc
Outcome results
None listed