Cost-effectiveness of Reduction Mammaplasty

Study Overview
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Brief Summary
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Several works show breast hypertrophy as pain cause, postural alterations, dermatitis and decrease of the functional capacity and of the self-esteem. The economical evaluations are destined to esteem the costs in alternative ways of attendance to the health, comparing, for instance, clinical strategies with surgical strategies. OBJECTIVE: To analyze cost-effectiveness in reduction mammaplasty.

Detailed Description
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Design: This is a primary, prospective, analytical, controlled study in humans. Settings: Data will be collected at the Plastic Surgery and Orthopedic and Traumatology Outpatient Clinics of the Samuel Libânio General Hospital (Hospital das Clínicas Samuel Libânio, HCSL), Pouso Alegre, MG, Brazil, in july/2008-december 2009. Participants: Fifty women with breast hypertrophy (25 study group and 25 control group) according to the Sacchini index,12 aged 18 to 59 years, were consecutively selected to participate in this study. Pregnant women, and patients who gave birth or were breastfeeding less than one year before the beginning of the study, as well as patients with uncontrolled systemic diseases, acute diseases, breast asymmetry, who had undergone breast or spine surgery, and who had body-mass index (BMI) lower than 18.5 kg/m2 (low body weight) or greater than 30 kg/m2 (obese women) were excluded from the study. Instruments: Pain intensity in the cervical, dorsal and lumbar regions of the back has been assessed using a visual analogue scale (VAS). also will be used SF36, HAQ 20 and SF-6D.

Official Title
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Cost-effectiveness of Reduction Mammaplasty

Conditions
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Breast,Hypertrophy, Cost-effectiveness

Intervention / Treatment
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* Procedure: reduction mammaplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with breast hypertrophy according to the Sacchini index Exclusion Criteria: Pregnant women Patients who gave birth or were breastfeeding less than one year before the beginning of the study Patients with uncontrolled systemic diseases, acute diseases, or breast asymmetry Patients who had undergone breast or spine surgery Patients who had body-mass index (BMI) lower than 18.5 kg/m2 (low body weight) or greater than 30 kg/m2 (obese women)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: reduction mammaplasty<br>submitted to surgery | Procedure: reduction mammaplasty<br>* patients submitted to reduction mammaplasty<br>|
| No Intervention: not reduction mammaplasty<br>not submitted to surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total cost for procedure will be calculated with accuracy through the Brazilian software TASY. To evaluate the effectiveness will be used the SHORT FORM 36, Visual Analogue Scale, Stanford Health Assessment Questionnaire 20 and SHORT FORM-6D |  | before the surgery (baseline) | 
| The total cost for procedure will be calculated with accuracy through the Brazilian software TASY. To evaluate the effectiveness will be used the SHORT FORM 36, Visual Analogue Scale, Stanford Health Assessment Questionnaire 20 and SHORT FORM-6D |  | 3 months after surgery | 
| The total cost for procedure will be calculated with accuracy through the Brazilian software TASY. To evaluate the effectiveness will be used the SHORT FORM 36, Visual Analogue Scale, Stanford Health Assessment Questionnaire 20 and SHORT FORM-6D |  | 6 months after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality-Adjusted Life Years:A measurement index, Cost-Benefit Analysis:A method of comparing costs, Mammaplasty, QALY, Health-related quality of life, Cost-effectiveness, Breast