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NCT Number: NCT06532955

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

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.

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Key information

Conditions

Lymphedema Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Arm Lymphedema of Limb Lymphedema of Upper Arm Lymphedema of Upper Limb Lymphedema, Breast Cancer Lymphedema, Non-Filarial Lymphedema, Secondary Lymphedema; Surgical Neoplasm Metastasis Neoplasms Neoplastic Processes Non-Filarial Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center+

Maastricht, Limburg, 6229HX, Netherlands

Location status: Recruiting

Location contact

Alieske Kleeven, MSc

CONTACT

[email protected]

+31(0)433877481

Shan Shan Qiu Shao, MSc, PhD

PRINCIPAL_INVESTIGATOR

Tom van Mulken, MSc

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lymphaticovenous anastomosis using Microsure Motion Stabilizer

Device

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.

Other names: LVA, Lympahticovenular anastomosis, Lymphovenous bypass, Lymphatic-venous shunt, Robot-assisted LVA

Lymphaticovenous anastomosis (manual)

Procedure

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

Other names: LVA, Lymphaticovenous anastomosis, Lymphovenous bypass, Lymphatic-venous shunt

Primary outcomes

  1. Efficiency of lymphaticovenous anastomosis (LVA)

    Time frame: 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 outcomes

  1. Duration of the surgery

    Time frame: 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

  2. Errors during surgery

    Time frame: 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

  3. Perioperative complications

    Time frame: 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.

  4. Surgeon's satisfaction with the procedure

    Time frame: 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.

  5. Surgeon's learning curve with the procedure in practise

    Time frame: 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.

  6. Patient's convenience during the surgery

    Time frame: 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.

  7. Arm circumference over time

    Time frame: 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.

  8. Arm volume over time

    Time frame: At baseline, 3, 6, and 12 months following LVA

    Water volumetry assess the arm volume over time

  9. Patient's symptoms over time

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alieske Kleeven, MSc

CONTACT

[email protected]

+31(0)433877481

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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