Lymphedema, Breast Cancer
Conditions
Brief summary
Lymphedema is defined as a chronic condition, caused by lymphostasis. A major part in the Western world consists of iatrogenic lymphedema caused by surgery to the lymph nodes of the axilla or groin. Prophylactic lymphovenous anastomosis (LVA) could be beneficial in the prevention of lymphedema of the extremities.
Detailed description
The investigator is performing a blinded randomized prospective study on 80 patients undergoing an axilla dissection for their breast cancer treatment. One group will receive a LVA at the time of their axilla dissection. Other group will receive standard of care. Follow-up is 2 year.
Interventions
PROCEDUREAxilla dissection + Lymphovenous anastomosis
surgical bypass between lymphatic vessel and vein
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
blinded randomized prospective
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* lymph node + breast cancer requiring dissection
Exclusion criteria
* previous lymphedema * BMI \>35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The volume via circumferential measurements: swelling < 5% | 2 years | Comparing the volume of the arm at each study visit via circumferential measurements: swelling \< 5% |
Countries
Belgium
Contacts
Primary ContactBernard Depypere, MD
Backup ContactJessie De Kinder
Outcome results
None listed