Breast,HypertrophyNCT00992368
Cost-effectiveness of Reduction Mammaplasty
A study testing reduction mammaplasty in people with Breast,Hypertrophy and Cost-effectiveness, run by Federal University of São Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast,Hypertrophy, Cost-effectiveness
- What is being tested?
- reduction mammaplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2008to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with breast hypertrophy according to the Sacchini index
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- Design: This is a primary, prospective, analytical, controlled study in humans.
- 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.
- 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.
- 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.
- Conditions
- Breast,Hypertrophy, Cost-effectiveness
- Being tested
- reduction mammaplasty
- Keywords
- 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
- Medical subject headings
- Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduction mammaplastyProcedure or surgery
patients submitted to reduction mammaplasty
| Study group | Role | What they receive |
|---|---|---|
| reduction mammaplasty | Active comparator | submitted to surgery Receives: Procedure: reduction mammaplasty |
| not reduction mammaplasty | No intervention | not submitted to surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast,HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Vale do Sapucai
- Responsible party
- Principal investigator, CARLOS DELANO MUNDIM ARAUJO, Federal University of São Paulo
- Investigators
- CARLOS DM ARAUJO, MD, PhD, Principal investigator, Federal University of São PauloDANIELA F VEIGA, MD, PhD, Study director, Federal University of São PauloBERNARDO S HOCHMAN, MD, PhD, Study director, Federal University of São PauloLUIZ EF ABLA, MD, PhD, Study director, Federal University of São PauloLYDIA M FERREIRA, MD, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992368
- Sponsor's protocol ID
- 1788.08
- Status last verified
- Mar 2014
- First submitted
- 7 Oct 2009
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15446755Araujo 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.
PubMed 24973340
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Reduction Mammaplasty
- ClinicalTrials.gov ID
- NCT00992368
- Acronym / sponsor ID
- 1788.08
- Conditions
- Breast,Hypertrophy, Cost-effectiveness
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Universidade do Vale do Sapucai
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Design: This is a primary, prospective, analytical, controlled study in humans.
- 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.
- 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.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reduction mammaplasty | Active comparator | Procedure: reduction mammaplastysubmitted to surgery |
| not reduction mammaplasty | No intervention | –not submitted to surgery |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with breast hypertrophy according to the Sacchini index
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reduction mammaplastypatients submitted to reduction mammaplasty | Procedure or surgery | reduction mammaplasty |
Primary outcome
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)
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
- Results publication: PubMed 15446755Taylor 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.
- Derived from this study: PubMed 24973340Araujo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CARLOS DM ARAUJO, MD, PhD principal investigator
Federal University of São Paulo
DANIELA F VEIGA, MD, PhD study director
Federal University of São Paulo
BERNARDO S HOCHMAN, MD, PhD study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reduction mammaplasty in people with Breast,Hypertrophy and Cost-effectiveness, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00992368, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.