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Trial Title:
LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema
NCT ID:
NCT05601037
Condition:
Lymphedema, Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
blinded randomized prospective
Primary purpose:
Prevention
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
Axilla dissection + Lymphovenous anastomosis
Description:
surgical bypass between lymphatic vessel and vein
Arm group label:
Axilla dissection + Lymphevenous Anastomosis
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- lymph node + breast cancer requiring dissection
Exclusion Criteria:
- previous lymphedema
- BMI >35
Gender:
Female
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
UZ GENT
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Start date:
June 30, 2021
Completion date:
December 27, 2026
Lead sponsor:
Agency:
University Hospital, Ghent
Agency class:
Other
Source:
University Hospital, Ghent
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05601037
