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Halted prematurely due to low enrollment
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This study will assess the impact of lymphaticovenous microanastomosis in volume reduction of postmastectomy upper extremity lymphedema. We hypothesize that multiple lymphaticovenous micro-anastomosis in the distal arm will result in the reduction of volume and improvement in quality of life of patients with post-mastectomy lymphedema
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lymphaticovenous Micro-Anastomosis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lymphaticovenous Micro-Anastomosis | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery | Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure. | 3 and 6 months from surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauricio Moreno, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lymphaticovenous Micro-Anastomosis | Lymphaticovenous Micro-Anastomosis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lymphaticovenous Micro-Anastomosis | Lymphaticovenous Micro-Anastomosis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery | Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure. | Early termination leading to small numbers of subjects.Outcome measures not computed because data would not be statistically relevant. | Posted | 3 and 6 months from surgery |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lymphaticovenous Micro-Anastomosis | Lymphaticovenous Micro-Anastomosis | 0 |
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Early termination leading to small numbers of subjects. Outcome measures not computed because data would not be statistically relevant.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Scanlan | University of Arkansas for Medical Sciences | 5016868274 | BScanlan@uams.edu |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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A lymphatic diversion with lymphaticovenous microanastomosis will be performed.
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Count of Participants | Number of participants | Count of Participants | Participants |
|
|
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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