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Immediate lymphatic reconstruction (ILR) is a novel surgical approach performed at the time of initial lymph node dissection with the goal of preventing lymphedema.(Chang et al. 2020) It involves the identification of lymphatic channels that are transected after lymph node dissection and microsurgical anastomosis of one or more lymphatic channel with a local recipient vein to re-direct upper extremity lymphatic drainage. Although ILR carries significant promise in prevention of lymphedema, there is a lack of high-level evidence supporting its efficacy because it is a novel surgical technique that is only offered at a few centers and not routinely covered by insurance carriers yet. The University of Chicago Comprehensive Cancer Center (UCCCC) is one of the busiest microsurgery centers performing this procedure, and, as a Lymphedema Center of Excellence, is in a unique position to investigate the efficacy of ILR in preventing lymphedema. In addition, the University has access to a world class microbiome research facility and colleagues. To our knowledge, there is no information on the skin microbiome of the axilla in patients undergoing treatment for breast cancer or those at risk for developing lymphedema. Further exploratory studies such as this in a diverse patient population may lead to practice changing research in our approach to lymphedema management and prevention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients who are potential candidates for immediate lymphatic reconstruction (ILR) | potential candidates for ILR based on possible nodal involvement assessed preoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patients who are candidates for immediate lymphatic reconstruction | Other | potential candidates for ILR based on possible nodal involvement assessed preoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of immediate lymphatic reconstruction (ILR) based on limb circumference of each arm | post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months. | |
| the efficacy of immediate lymphatic reconstruction (ILR) based on volume | post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months. | |
| the efficacy of immediate lymphatic reconstruction (ILR) based on bioimpedance spectroscopy measurements of affected and unaffected limbs of women before and after surgery. | Bioimpedance spectroscopy is a non-invasive technology that measures total body water, and both extracellular and intracellular fluid volumes. | post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months. |
| Measure | Description | Time Frame |
|---|---|---|
| the impact of ILR on validated patient reported outcome tool using the lymphedema life impact scale (LLIS) | This is an 18 questionnaire that has a scale from 0 (no pain) to 4 (severe pain) | post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the Axillary Microbiome in ILR-Treated and Untreated Limbs | Characterize the axillary microbiome in limbs that have been treated with ILR compared to those that were unaffected before and after surgery. | post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months. |
Inclusion Criteria:
potential candidates for ILR based on possible nodal involvement assessed preoperatively.
Exclusion Criteria:
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patients who are potential candidates for ILR based on possible nodal involvement assessed preoperatively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Summer Hanson, MD, PhD, FACS | Contact | (773) 702-6302 | sehanson@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Summer Hanson, MD, PhD, FACS | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University o Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| the impact of ILR on validated patient reported outcome tool using The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire |
This is a 30 questionnaire that has a scale from 1 (No difficulty) to 5 (unable) |
| post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months. |
| the impact of ILR on validated patient reported outcome tool using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) | This is a 10 questionnaire that scales from unable to do it (1) to not difficult (3). | post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months. |