Cost-effectiveness of Reduction Mammaplasty

Federal University of São Paulo

Status: Completed

Conditions: Breast,Hypertrophy; Cost-effectiveness

Treatments: Procedure: reduction mammaplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00992368

1788.08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

reduction mammaplasty

Active Comparator group

Description:

submitted to surgery

Treatment:

Procedure: reduction mammaplasty

not reduction mammaplasty

No Intervention group

Description:

not submitted to surgery