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Policy approved describing all procedures as standard of care
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The purpose of the Fibroid Registry is to provide a comprehensive database that captures patient characteristics, clinical outcomes and pot-treatment quality of life measures for patients treated for uterine fibroids. This database will serve as a platform for future comparative effectiveness and other health services research studies.
The proposed research will be a prospective registry study of patients treated for uterine fibroids at the Fibroid Center located at South Miami Hospitals Center for Women and Infants.
Our objective is to establish the Fibroid Registry:
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| Measure | Description | Time Frame |
|---|---|---|
| Short, middle and long term clinical outcomes data that will help inform and facilitate the decision making process of clinicians and patients on the safest and most effective treatment for symptomatic uterine myomas, leiomyomas, or fibromas. | Data elements will be collected at baseline prior procedure, at follow up for 30 days (± 5 days), 6 months (±5 days) and 12 months (± 5 days) post procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Critically evaluate quality of procedures being performed and ultimately establish a gold standard of care based upon patient, clinical outcomes and characteristics (Fibroid Questionnaire & Quality of Life Questionnaire) | Such registry will enable us to address a number of research questions, for instance:
|
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Inclusion Criteria:
Exclusion Criteria:
1)Patients that decline to participate and/or are younger than 18 or older than 89.
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Outpatients seen for fibroid treatment services.
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Sepulveda, M.D | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Miami Hospital | Miami | Florida | 33143 | United States |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D005350 | Fibroma |
| D009214 | Myoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Baseline prior procedure, at follow up for 30 days (± 5 days), 6 months (±5 days) and 12 months (± 5 days) post procedure. |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |