Lymphedema Arm
Conditions
Keywords
Breast Cancer, Lymphedema
Brief summary
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.
Detailed description
In the intervention group, LVB was performed with intima-to-intima coaptation using the super microsurgery technique. The anastomosis was between the afferent lymphatic vessel and the recipient vein. The upper extremity lymphedema (UEL) index and indocyanine green (ICG) lymphography are utilized to evaluate the progression of lymphedema.
Interventions
PROCEDURELymphovenous bypass (LVB)
The 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.
Sponsors
Dharmais National Cancer Center Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Blinding is implemented in two conditions: the principal researcher (Bayu Brahma) will not know the patient's identity or medical history when assessing indocyanine green (ICG) lymphography results, and the patients will not see the type of treatment they received.
Intervention model description
This study is a single-blind, pragmatic, parallel arm randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BCRL improvement rate | 24 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life in lymphedema | 24 months | 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 | 24 months | Complications such as seroma, hematoma, wound separation, bleeding, and wound infection can be seen after surgery. |
Countries
Indonesia
Contacts
Primary ContactAdhitya B Perdana, MEpi
Outcome results
None listed