NCT00992368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

1.4 years

First QC Date

October 7, 2009

Last Update Submit

March 3, 2014

Conditions

Breast,HypertrophyCost-effectiveness

Keywords

Quality-Adjusted Life Years:A measurement indexCost-Benefit Analysis:A method of comparing costsMammaplastyQALYHealth-related quality of lifeCost-effectivenessBreast

Outcome Measures

Primary Outcomes (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

    before the surgery (baseline)

  • 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

  • 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

Study Arms (2)

reduction mammaplasty

ACTIVE COMPARATOR

submitted to surgery

Procedure: reduction mammaplasty

not reduction mammaplasty

NO INTERVENTION

not submitted to surgery

Interventions

reduction mammaplastyPROCEDURE

patients submitted to reduction mammaplasty

reduction mammaplasty

Eligibility Criteria

Age18 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women with breast hypertrophy according to the Sacchini index

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carlos Dm Araujo

Pouso Alegre, Minas Gerais, 37550000, Brazil

Location

Related Publications (2)

  • 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. doi: 10.1017/s0266462304001072.

    PMID: 15446755RESULT

  • Araujo CD, Veiga DF, Hochman BS, Abla LE, Oliveira AC, Novo NF, Veiga-Filho J, Ferreira LM. Cost-utility of reduction mammaplasty assessed for the Brazilian public health system. Aesthet Surg J. 2014 Nov;34(8):1198-204. doi: 10.1177/1090820X14539972. Epub 2014 Jun 27.

    PMID: 24973340DERIVED

MeSH Terms

Conditions

Gigantomastia

Study Officials

  • CARLOS DM ARAUJO, MD, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

  • LYDIA M FERREIRA, MD, PhD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 9, 2009

Study Start

July 1, 2008

Primary Completion

December 1, 2009

Study Completion

June 1, 2012

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations

BR(1)