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Completed

NCT Number: NCT00992368

Cost-effectiveness of Reduction Mammaplasty

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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Key information

Age range

18 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Carlos Dm Araujo

Pouso Alegre, Minas Gerais, 37550000, Brazil

About this study

  • Design: This is a primary, prospective, analytical, controlled study in humans.
  • 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.
  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

reduction mammaplasty

Procedure

patients submitted to reduction mammaplasty

Primary outcomes

  1. 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

    Time frame: before the surgery (baseline)

  2. 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

    Time frame: 3 months after surgery

  3. 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

    Time frame: 6 months after the surgery

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Universidade do Vale do Sapucai

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Oct 9, 2009
Registry last updated
Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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