Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: LYMPHA procedure: LYMPHA procedure consists of lymphatic-venous anastomosis. It will be performed after the standard of care surgery-mastectomy and lymph node dissection. After completi
Sponsors
Tata Memorial Hospital
Not Any
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female subjects aged >18years 2.Unilateral disease 3.All patients undergoing axillary lymph node dissection with lumpectomy or mastectomy
Exclusion criteria
Exclusion criteria: 1.Bilateral disease 2.Prior injury or radiation to axilla 3.Patients undergoing primary breast reconstruction 4.Patients undergoing sentinel lymph node biopsy / Axillary sampling alone 5.Established lymphedema of upper limbs 6.Pregnant patients 7.Patients enrolled in exercise study, COMPREL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate success of lymphatic-venous anastomosisTimepoint: arm circumference measurement and BIS (bio impedance spectroscopy) of both upper arm will also be done pre and post operative and post operative 6th month, 1 year and 2nd year visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the feasibility of procedure.Timepoint: during and at the end of surgery and post postoperative 6 month visit;2.Lymphedema development at 1 year, 2 years and long term follow up.Timepoint: post operative 1yr, 2yr and then every yearly visit till patient survival;3.To design a protocol for a randomised control comparison of lymphedema rates in patients receiving lymph node dissection with lymphatic-venous bypass versus lymph node dissection alone.Timepoint: after completion of 1 year study visit by all participant | — |
Countries
India
Contacts
Public ContactDr Vinay Kant Shankhdhar
Tata Memorial Hospital
Outcome results
None listed