The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema
- Conditions
- Lymphedema ArmLymphedema of Upper LimbLymphedema, Non-FilarialLymphedema of Upper ArmLymphedema; SurgicalLymphedema of LimbLymphedema, Breast CancerLymphedemaLymphedema, Secondary
- Interventions
- Procedure: Lymphaticovenous anastomosis (manual)Device: Lymphaticovenous anastomosis using Microsure Motion Stabilizer
- Registration Number
- NCT06532955
- Lead Sponsor
- Maastricht University Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lymphaticovenous anastomosis Lymphaticovenous anastomosis (manual) Patients in this group undergo lymphaticovenous anastomosis at one or more locations on the affected arm. The procedure is performed under local anesthesia. Incisions are made at the sites where lymphatic vessels are obstructed, ensuring no harm to the viable part of the lymphatic system. The location(s) are determined prior to surgery using ICG lymphography. LVA(s) are made in the subdermal plane with the aid of a surgical microscope. Generally, 1 to 4 LVAs are made. The LVAs are madeusing a surgical microscope and the operation takes approximately 90 minutes. Lymphaticovenous anastomosis using Microsure Motion Stabilizer Lymphaticovenous anastomosis using Microsure Motion Stabilizer Patients in this group undergo robot-assisted lymphaticovenous anastomosis at one or more locations on the affected arm. The procedure is performed under local anesthesia. Incisions are made at the sites where lymphatic vessels are obstructed, ensuring no harm to the viable part of the lymphatic system. The location(s) are determined prior to surgery using ICG lymphography. LVA(s) are made in the subdermal plane with the aid of a surgical microscope. Generally, 1 to 4 LVAs are made. The LVAs are madeusing a surgical microscope and the operation takes approximately 240 minutes.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
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.
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.
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.
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 volume over time At baseline, 3, 6, and 12 months following LVA Water volumetry assess the arm volume over time
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.
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.
Trial Locations
- Locations (1)
Maastricht University Medical Center+
🇳🇱Maastricht, Limburg, Netherlands