Cost-effectiveness of Reduction Mammaplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast,Hypertrophy Cost-effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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reduction mammaplasty

submitted to surgery

Group Type ACTIVE_COMPARATOR

reduction mammaplasty

Intervention Type PROCEDURE

patients submitted to reduction mammaplasty

not reduction mammaplasty

not submitted to surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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reduction mammaplasty

patients submitted to reduction mammaplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes