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Cost-effectiveness of Reduction Mammaplasty

Cost-effectiveness of Reduction Mammaplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00992368
Enrollment
50
Registered
2009-10-09
Start date
2008-07-31
Completion date
2012-06-30
Last updated
2014-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

patients submitted to reduction mammaplasty

Sponsors

Universidade do Vale do Sapucai
CollaboratorOTHER
Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 59 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime 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-6Dbefore the surgery (baseline)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026