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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

October 7, 2009
March 14, 2011
July 2008
December 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00992368 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cost-effectiveness of Reduction Mammaplasty
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.
  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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Hypertrophy of Breast
  • Cost-effectiveness
Procedure: reduction mammaplasty
patients submitted to reduction mammaplasty
  • Active Comparator: reduction mammaplasty
    submitted to surgery
    Intervention: Procedure: reduction mammaplasty
  • No Intervention: not reduction mammaplasty
    not submitted to surgery
    Intervention: Procedure: reduction mammaplasty
Taylor AJ, Tate D, Brandberg Y, Blomqvist L. Cost-effectiveness of reduction mammaplasty. Int J Technol Assess Health Care. 2004 Summer;20(3):269-73.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2010
December 2009   (final data collection date for primary outcome measure)

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)
Female
18 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00992368
1788.08
No
CARLOS DELANO MUNDIM ARAUJO/ COST EFFECTIVENESS OF REDUCTION MAMAPLASTY, FEDERAL UNIVERSITY OF SÃO PAULO
Federal University of São Paulo
Universidade do Vale do Sapucai
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
Federal University of São Paulo
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP