The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema
NCT Number: NCT06532955
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
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
Interventions: DEVICE: Lymphaticovenous anastomosis using Microsure Motion Stabilizer|PROCEDURE: Lymphaticovenous anastomosis (manual)
Sponsor: Maastricht University Medical Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-06-01
Completion Date: 2026-01-01
Locations: Maastricht University Medical Center+, Maastricht, Limburg, 6229HX, Netherlands

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.

Primary Outcome Measures: 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., Assessed at one moment during, maximally up to 1 year postoperatively
Secondary Outcome Measures: 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, Assessed once and registered directly after the surgery|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, Assessed during surgery and registered directly after the surgery on the same day as the surgery|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., Assessed during surgery and postoperatively, in case any occur|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., Assessed directly after surgery, on the same day as the surgery|Surgeon's learning curve with the procedure in practise, To study the learning curve will be calculated by using a curve fitting method to model learning curves., Assessed through study completion, an average of 1 year|Patient's convenience during 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., Assessed directly postoperatively,on the same day as the surgery|Arm circumference over time, 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., At baseline, 3, 6, and 12 months following LVA|Arm volume over time, Water volumetry assess the arm volume over time, At baseline, 3, 6, and 12 months following LVA|Patient's symptoms over time, 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., At baseline, 3, 6 and 12 months following LVA