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Cost-effectiveness of Reduction Mammaplasty

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ClinicalTrials.gov Identifier: NCT00992368
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : March 4, 2014
Sponsor:
Collaborator:
Universidade do Vale do Sapucai
Information provided by (Responsible Party):
CARLOS DELANO MUNDIM ARAUJO, Federal University of São Paulo

Brief 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.


Condition or disease Intervention/treatment Phase
Breast,Hypertrophy Cost-effectiveness Procedure: reduction mammaplasty Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Cost-effectiveness of Reduction Mammaplasty
Study Start Date : July 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: reduction mammaplasty
submitted to surgery
Procedure: reduction mammaplasty
patients submitted to reduction mammaplasty
No Intervention: not reduction mammaplasty
not submitted to surgery



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CARLOS DELANO MUNDIM ARAUJO, MD, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00992368     History of Changes
Other Study ID Numbers: 1788.08
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014

Keywords provided by CARLOS DELANO MUNDIM ARAUJO, 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