Cost-effectiveness of Reduction Mammaplasty

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00992368
Study type	Interventional
Source	Federal University of São Paulo
Contact
Status	Completed
Phase	N/A
Start date	July 2008
Completion date	June 2012

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