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ID
Source
Brief title
Health condition
lymphedema
robotic (super)microsurgery
lymphatico-venular anastomosis (LVA)
lymfoedeem
robot-geassisteerde (super)microchirurgie
lymphatico-veneuze anastomose (LVA)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of the anastomosis
Secondary outcome
Duration of the surgery
Errors during surgery & peri-operative complications
Surgeons' satisfaction with the procedure
Patients' convenience during the surgery
Arm volume over time
Patients' symptoms over time
Background summary
Microsurgery facilitates procedures such as transplantation of tissue as well as lymphedema treatment. Currently the surgeon¡¯s hands are the limiting factor in microsurgical performance. Robot-assistance increases the movement precision and might therefore be of great importance for the advancement of microsurgery in the world.
This pilot study assesses the performance of robot-assisted microsurgery. Lymphatico-venular anastomosis is the most difficult procedure in microsurgery at this moment (i.e. supermicrosurgery). This 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.
Study objective
A newly, dedicated robotic system for (super)microsurgery can increase efficiency and precison of microsurgical skills.
Study design
Primary and secondary outcomes will be assessed during (and after) surgery.
Intervention
Robot-assisted LVA versus Conventional LVA
Inclusion criteria
Female gender
Age 18 years or older
Treated for primary early stage breast cancer
Early stage lymphedema of the arm (stage 1 or 2 on ISL classification)
ELV ¡Ý10%
Suffering unilateral disease and treatment
Exclusion criteria
Male gender
Stage 3 lymphedema of the arm
Recurrent breast cancer
Distant breast cancer metastases
Current substance abuse
History of marcaine or indocyanine green allergy
Non-viable lymphatic system as determined by near infrared imaging
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6291 |
| NTR-old | NTR6465 |
| CCMO | NL60199.068.16 |
| OMON | NL-OMON55850 |