Cost-effectiveness of Reduction Mammaplasty
Primary Purpose
Breast,Hypertrophy, Cost-effectiveness
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
reduction mammaplasty
Sponsored by
About this trial
This is an interventional health services research trial for Breast,Hypertrophy focused on measuring 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
Eligibility Criteria
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)
Sites / Locations
- Carlos Dm Araujo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
reduction mammaplasty
not reduction mammaplasty
Arm Description
submitted to surgery
not submitted to surgery
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00992368
First Posted
October 7, 2009
Last Updated
March 3, 2014
Sponsor
Federal University of São Paulo
Collaborators
Universidade do Vale do Sapucai
1. Study Identification
Unique Protocol Identification Number
NCT00992368
Brief Title
Cost-effectiveness of Reduction Mammaplasty
Official Title
Cost-effectiveness of Reduction Mammaplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Universidade do Vale do Sapucai
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast,Hypertrophy, Cost-effectiveness
Keywords
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
reduction mammaplasty
Arm Type
Active Comparator
Arm Description
submitted to surgery
Arm Title
not reduction mammaplasty
Arm Type
No Intervention
Arm Description
not submitted to surgery
Intervention Type
Procedure
Intervention Name(s)
reduction mammaplasty
Intervention Description
patients submitted to reduction mammaplasty
Primary Outcome Measure Information:
Title
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)
Title
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
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CARLOS DM ARAUJO, MD, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DANIELA F VEIGA, MD, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
BERNARDO S HOCHMAN, MD, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
LUIZ EF ABLA, MD, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
LYDIA M FERREIRA, MD, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Carlos Dm Araujo
City
Pouso Alegre
State/Province
MG
ZIP/Postal Code
37550000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
15446755
Citation
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.
Results Reference
result
PubMed Identifier
24973340
Citation
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.
Results Reference
derived
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Cost-effectiveness of Reduction Mammaplasty
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