Pilot study on robot-assisted microsurgical lymphatico-venular anastomosis
Recruiting
- Conditions
- lymphedema10040795
- Registration Number
- NL-OMON55850
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
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 >=10%
- 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
- Previous LVA in the arm with lymphedema (<10 years)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome parameter is LVA anastomosis technique and the quality of the<br /><br>anastomosis. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures include duration of surgery, technical errors during<br /><br>surgery & complications peri-operatively, surgeon*s satisfaction with the LVA<br /><br>procedure, surgeon*s learning curve with the procedure in practise, the<br /><br>patients* convenience during surgery, arm volume over time and patient*s<br /><br>symptom development over time.</p><br>