This study aims to evaluate the effectiveness of the Lymphovenous Bypass (LVB) procedure compared to physiotherapy alone as secondary prevention of lymphedema in breast cancer patients undergoing axillary lymph node dissection.
Breast cancer patients aged ≥ 18 years with an ECOG score > 1
Breast cancer patients with post-axillary lymph node dissection diagnosed with stage 0 and I lymphedema.
Those who have never undergone lymphedema physiotherapy.
Patients with dermal backflow before axillary lymph node dissection (ALND).
Patients with breast cancer lymphedema who are unable to undergo a 24-month follow-up at Dharmais Cancer Hospital.
Patients with iodine allergy, severe asthma, decreased kidney function, pregnancy, or breastfeeding.
Parallel
Lymphovenous bypass (LVB)
Procedure/SurgeryThe Lymphovenous Bypass (LVB) procedure in this study is a microsurgical supermicrosurgery-based intervention specifically designed for the secondary prevention of breast cancer-related lymphedema following axillary lymph node dissection.
BCRL improvement rate
BCRL definition: Post-operation subject condition with the presence of minimum DB 2 with one or both symptoms (swelling, heaviness), and an increment of UEL index \>10% compared to pre-operation OR Post-operation subject condition with presence of ≥ DB 2 with minimum area 30% in one arm region in one of the arm lymphatic pathways (anterior or posterior), without presence of symptoms (swelling or heaviness), and increment of UEL index \>10% compared to pre-operation. International Society of Lymphology (ISL) stage 1 definition: An early stage of lymphedema is characterized by soft tissue swelling that may subside with limb elevation or overnight rest, without permanent structural changes. BCRL improvement : Improvement in ICG lymphography stage with or without clinical signs (UEL \<10% and or symptoms improvement)
Quality of life in lymphedema
QLQ-BR23 is a supplement to the EORTC QLQ-30, specific to breast cancer patients, containing 23 questions and scored from 0 (not at all) to 4 (very much). To evaluate the quality of life, we asked three questions about the arm (pain, swelling, and mobility issues). The quality of life decreases with a higher score.
Adverse event of lymphedema
Complications such as seroma, hematoma, wound separation, bleeding, and wound infection can be seen after surgery.
Click on the lead sponsor to view all of their trials.
