Cost-effectiveness of Reduction Mammaplasty

Not Applicable

Completed

• Conditions: Breast,Hypertrophy; Cost-effectiveness
• Interventions: Procedure: reduction mammaplasty

• Registration Number: NCT00992368
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Primary Completion: 2009-12
• Study Completion: 2012-06
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-03
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
reduction mammaplasty	reduction mammaplasty	submitted to surgery

Primary Outcome Measures

Name	Time	Method
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	6 months after the surgery

Trial Locations

Locations (1)

Carlos Dm Araujo; 🇧🇷 Pouso Alegre, MG, Brazil