Clinical trial NCT00992368: Cost-effectiveness of Reduction Mammaplasty
Official title: Cost-effectiveness of Reduction Mammaplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Universidade do Vale do Sapucai
First posted: 2009-10-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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: 1. Design: This is a primary, prospective, analytical, controlled study in humans.
2. 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.
3. 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.
4. 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.

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)

Primary outcomes:
measure: 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
timeFrame: before the surgery (baseline)
measure: 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
timeFrame: 3 months after surgery
measure: 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
timeFrame: 6 months after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Carlos Dm Araujo
state: MG
Study officials:
affiliation: Federal University of São Paulo
name: CARLOS DM ARAUJO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: DANIELA F VEIGA, MD, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: BERNARDO S HOCHMAN, MD, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: LUIZ EF ABLA, MD, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: LYDIA M FERREIRA, MD, PhD
role: STUDY_CHAIR
References:
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.
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.