Cost-effectiveness of Reduction Mammaplasty

Cost-effectiveness Clinical Trial

Official title:

Cost-effectiveness of Reduction Mammaplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992368
• Other study ID #: 1788.08
• Status: Completed
• Phase: N/A
• First received: October 7, 2009
• Last updated: March 3, 2014
• Start date: July 2008
• Est. completion date: June 2012

Study information

• Verified date: March 2014
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breast,Hypertrophy
• Cost-effectiveness
• Hypertrophy

Intervention

Procedure:
• reduction mammaplasty
patients submitted to reduction mammaplasty

Locations

Country	Name	City	State
Brazil	Carlos Dm Araujo	Pouso Alegre	MG

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		before the surgery (baseline)	No
Primary	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		3 months after surgery	No
Primary	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		6 months after the surgery	No