Preventing Lymphedema in Axillary Lymph Node Dissection
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About
The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.
Full description
All subjects will undergo an axillary lymph node dissection (ALND). Cluster randomization will determine which of these subjects will have the ARM with LVB and which subjects will have the ALND without this technique. As a baseline, all subjects will have the circumference of their arms measured and complete a questionnaire about lymphedema. Performing the measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after surgery.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
- Patients scheduled to undergo an axillary lymph node dissection
- Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings
- English speaking
Exclusion Criteria
- Prior ipsilateral axillary lymph node dissection
- Prior ipsilateral axillary radiation
- Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement
- Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema.
- Pregnant patients cannot participate in the substudy
Trial design
Primary purpose
Allocation
Interventional model
Masking
264 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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