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Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis
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.
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands
Start Date
June 1, 2017
Primary Completion Date
January 1, 2026
Completion Date
January 1, 2026
Last Updated
August 1, 2024
60
ESTIMATED participants
Lymphaticovenous anastomosis using Microsure Motion Stabilizer
DEVICE
Lymphaticovenous anastomosis (manual)
PROCEDURE
Lead Sponsor
Maastricht University Medical Center
NCT05628948
NCT06418282
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