Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.
Patients in the LYMPHA group undergo Axillary reverse mapping before the start of surgery, and after axillary lymph node resection, LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
72
Axillary reverse mapping is performed before surgery, axillary lymph node resection is performed, and 'LYMPHA' (Lymphatic microsurgical preventing healing approach) is performed, and the surgery is terminated. Subsequently, the occurrence of lymphedema is followed up.
In the control group, axillary lymph node resection is performed and the surgery is terminated without additional procedures. Subsequently, the occurrence of lymphedema is followed up.
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
RECRUITINGIncidence of lymphedema
To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 2 years after the surgery.
Time frame: 2 years after surgery
UEL index
To compare the UEL index
Time frame: 2 years after surgery
Changes in Lymphoscintigraphy
To compare the changes in lymphoscintigraphy presented by the change of transport index (TI)
Time frame: 2 years after surgery
Incidence of lymphedema
To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 5 years after the surgery.
Time frame: 5 years after surgery
5-year recurrence rate
To compare the recurrence rate
Time frame: 5 years after surgery
5-year overall survival rate
To compare the overall survival rate
Time frame: 5 years after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.