Cost-effectiveness of Reduction Mammaplasty
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
MG
-
Pouso Alegre, MG, Brazil, 37550000
- Carlos Dm Araujo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: reduction mammaplasty
submitted to surgery
|
patients submitted to reduction mammaplasty
|
|
No Intervention: not reduction mammaplasty
not submitted to surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: before the surgery (baseline)
|
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
Time Frame: 3 months after surgery
|
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
Time Frame: 6 months after the surgery
|
6 months after the surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: CARLOS DM ARAUJO, MD, PhD, Federal University of São Paulo
- Study Director: Daniela F Veiga, MD, PhD, Federal University of São Paulo
- Study Director: BERNARDO S HOCHMAN, MD, PhD, Federal University of São Paulo
- Study Director: LUIZ EF ABLA, MD, PhD, Federal University of São Paulo
- Study Chair: Lydia M Ferreira, MD, PhD, Federal University of São Paulo
Publications and helpful links
General Publications
- Taylor AJ, Tate D, Brandberg Y, Blomqvist L. Cost-effectiveness of reduction mammaplasty. Int J Technol Assess Health Care. 2004 Summer;20(3):269-73. doi: 10.1017/s0266462304001072.
- Araujo CD, Veiga DF, Hochman BS, Abla LE, Oliveira AC, Novo NF, Veiga-Filho J, Ferreira LM. Cost-utility of reduction mammaplasty assessed for the Brazilian public health system. Aesthet Surg J. 2014 Nov;34(8):1198-204. doi: 10.1177/1090820X14539972. Epub 2014 Jun 27.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1788.08
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