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Robot geassisteerde LVA: een pilot studie naar robot-geassisteerde microchirurgische lymfatico-veneuze anastomoses


- candidate number27313
- NTR NumberNTR6465
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mei-2017
- Secondary IDsNL60199.068.16 METC162053
- Public TitleRobot geassisteerde LVA: een pilot studie naar robot-geassisteerde microchirurgische lymfatico-veneuze anastomoses
- Scientific TitlePilot study on robot-assisted microsurgical lymphatico-venular anastomosis
- ACRONYMRobotic LVA study
- hypothesisA newly, dedicated robotic system for (super)microsurgery can increase efficiency and precison of microsurgical skills.
- Healt Condition(s) or Problem(s) studiedLymphedema, Robotic (super)microsurgery, Lymphatico-venular anastomosis (LVA)
- Inclusion criteriaFemale 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 ¡İ10%
Suffering unilateral disease and treatment
- Exclusion criteriaMale 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2017
- planned closingdate28-feb-2019
- Target number of participants20
- InterventionsRobot-assisted LVA versus Conventional LVA
- Primary outcomeEfficiency of LVA is measured assessing the quality of the completed lymphovenular anastomosis
- Secondary outcomeDuration of the surgery
Errors during surgery & peri-operative complications
Surgeon¡¯s satisfaction with the procedure
Patients¡¯ convenience during the surgery
Arm volume over time
Patient¡¯ symptoms over time
- TimepointsPrimary and secondary outcomes will be assessed during (and after) surgery.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. R.M. Schols
- CONTACT for SCIENTIFIC QUERIESMD PhD S.S. Qiu Shao
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Microsure
- Publicationshttps://www.ncbi.nlm.nih.gov/pubmed/28265793
- Brief summaryMicrosurgery 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.
- Main changes (audit trail)
- RECORD23-mei-2017 - 19-aug-2017


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