LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema
Not Applicable
Recruiting
- Conditions
- Lymphedema, Breast Cancer
- Interventions
- Procedure: Axilla dissection + Lymphovenous anastomosis
- Registration Number
- NCT05601037
- Lead Sponsor
- University Hospital, Ghent
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
- lymph node + breast cancer requiring dissection
Exclusion Criteria
- previous lymphedema
- BMI >35
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Axilla dissection + Lymphevenous Anastomosis Axilla dissection + Lymphovenous anastomosis Surgical bypass between lymphatic vessel and vein
- Primary Outcome Measures
Name Time Method The volume via circumferential measurements: swelling < 5% 2 years Comparing the volume of the arm at each study visit via circumferential measurements: swelling \< 5%
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UZ GENT
🇧🇪Gent, Oost-Vlaanderen, Belgium