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

Pilot study on robot-assisted microsurgical lymphatico-venular anastomosis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26829

Enrollment

Registered

2017-05-23

Start date

2017-06-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lymphedema robotic (super)microsurgery lymphatico-venular anastomosis (LVA) lymfoedeem robot-geassisteerde (super)microchirurgie lymphatico-veneuze anastomose (LVA)

Interventions

Robot-assisted LVA versus Conventional LVA

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Quality of the anastomosis	—

Secondary

Measure	Time frame
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	—

Contacts

Public ContactR.M. Schols

P. Debyelaan 25

rutger.schols@mumc.nl+31 (0)43 3881575

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)