Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2008-07-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Breast hypertrophy
Patients with macromastia will be evaluated in regard to sexual function and depression predictors at 3 moments: initial interview, after 3 months and after 6 months
No interventions assigned to this group
Reduction Mammaplasty
Breast hypertrophy patients randomized to this group will immediately be scheduled for reduction mammaplasty and will be will be evaluated in regard to sexual function and depression predictors preoperatively and 3 and 6 months postoperatively
Reduction mammaplasty
Sexual function of patients undergoing reduction mammaplasty will be assessed by the Female Sexual Function Index (FSFI) preoperatively and 3 and 6 months postoperatively.
Interventions
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Reduction mammaplasty
Sexual function of patients undergoing reduction mammaplasty will be assessed by the Female Sexual Function Index (FSFI) preoperatively and 3 and 6 months postoperatively.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* candidate to reduction mammaplasty
* healthy volunteer with normal volume breasts (control group)
* body mass index under 30Kg/m2
Exclusion Criteria
* body mass index over 30Kg/m2
* breast cancer history
* previous breast surgery
* hard smoking
18 Years
60 Years
FEMALE
Yes
Sponsors
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Universidade do Vale do Sapucai
OTHER
Daniela Francescato Veiga
OTHER
Responsible Party
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Daniela Francescato Veiga
Professor
Principal Investigators
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Flavia N Beraldo, PhD
Role: PRINCIPAL_INVESTIGATOR
UNIFESP and UNIVAS
Daniela F Veiga, MD, PhD
Role: STUDY_DIRECTOR
UNIFESP and UNIVAS
Lydia M Ferreira, MD, PhD
Role: STUDY_CHAIR
Federal University of São Paulo
Locations
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Hospital das Clínicas Samuel Libânio - UNIVÁS
Pouso Alegre, Minas Gerais, Brazil
Countries
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References
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Garcia ES, Veiga DF, Sabino-Neto M, Beraldo Cardoso FN, Batista IO, Leme RM, Cabral IV, Novo NF, Ferreira LM. Sensitivity of the Nipple-Areola Complex and Sexual Function Following Reduction Mammaplasty. Aesthet Surg J. 2015 Sep;35(7):NP193-202. doi: 10.1093/asj/sjv034.
Beraldo FN, Veiga DF, Veiga-Filho J, Garcia ES, Vilas-Boas GS, Juliano Y, Sabino-Neto M, Ferreira LM. Sexual Function and Depression Outcomes Among Breast Hypertrophy Patients Undergoing Reduction Mammaplasty: A Randomized Controlled Trial. Ann Plast Surg. 2016 Apr;76(4):379-82. doi: 10.1097/SAP.0000000000000380.
Other Identifiers
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Dinter 02
Identifier Type: -
Identifier Source: org_study_id
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