Clinical trial NCT02362009: South Miami Hospital Fibroid Registry
Official title: South Miami Hospital Fibroid Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Uterine Myomas, Leiomyomas, or Fibromas
Keywords: Myomas
Leiomyomas
Fibromas
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients seen for fibroid treatment services.

Brief summary: 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.

Detailed description: 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:

* To collect and review 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.
* To be able to critically evaluate the quality of procedures being performed and to ultimately establish a gold standard of care based upon patient and clinical outcomes and characteristics.
* To ultimately establish a gold standard of care based upon clinical outcomes and patient characteristics.

Eligibility criteria: Inclusion Criteria:

1. Patients seeking treatment for uterine myomas, leiomyomas, or fibromas.
2. Patients between the ages of 18-89.
3. Patients that agree to participate and sign consent.

Exclusion Criteria:

1)Patients that decline to participate and/or are younger than 18 or older than 89.

Primary outcomes:
measure: 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.
timeFrame: 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.
Secondary outcomes:
measure: 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)
timeFrame: Baseline prior procedure, at follow up for 30 days (± 5 days), 6 months (±5 days) and 12 months (± 5 days) post procedure.
Other outcomes:
Locations:
city: Miami
country: United States
facility: South Miami Hospital
state: Florida
Study officials:
affiliation: Principal Investigator
name: Jaime Sepulveda, M.D
role: PRINCIPAL_INVESTIGATOR
References: