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Cost-effectiveness of Reduction Mammaplasty

This study has been completed.
Sponsor:
Collaborator:
Universidade do Vale do Sapucai
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00992368
First received: October 7, 2009
Last updated: March 14, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Hypertrophy of Breast
Cost-effectiveness
 Procedure: reduction mammaplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Cost-effectiveness of Reduction Mammaplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: reduction mammaplasty
submitted to surgery
 Procedure: reduction mammaplasty
patients submitted to reduction mammaplasty
No Intervention: not reduction mammaplasty
not submitted to surgery
 Procedure: reduction mammaplasty
patients submitted to 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.
  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992368

Locations
Brazil
Carlos Dm Araujo
Pouso Alegre, MG, Brazil, 37550000
Sponsors and Collaborators
Federal University of São Paulo
Universidade do Vale do Sapucai
Investigators
Principal Investigator: CARLOS DM ARAUJO, MD, PhD Federal University of São Paulo
Study Director: DANIELA F VEIGA, MD, PhD Federal University of São Paulo
Study Director: BERNARDO S HOCHMAN, MD, PhD Federal University of São Paulo
Study Director: LUIZ EF ABLA, MD, PhD Federal University of São Paulo
Study Chair: LYDIA M FERREIRA, MD, PhD Federal University of São Paulo
  More Information

Publications:

Responsible Party: CARLOS DELANO MUNDIM ARAUJO/ COST EFFECTIVENESS OF REDUCTION MAMAPLASTY, FEDERAL UNIVERSITY OF SÃO PAULO
ClinicalTrials.gov Identifier: NCT00992368     History of Changes
Other Study ID Numbers: 1788.08
Study First Received: October 7, 2009
Last Updated: March 14, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Quality-Adjusted Life Years:A measurement index
Cost-Benefit Analysis:A method of comparing costs
Mammaplasty
QALY
 Health-related quality of life
Cost-effectiveness
Breast

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013