Sexuality After Reduction Mammaplasty

Study Overview
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Brief Summary
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The aim of this study is to determine the impact of reduction mammaplasty on sexuality and depression predictors in women with macromastia.

Detailed Description
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Breast hypertrophy is a common condition among women. Reduction mammaplasty is an effective and well established procedure performed for the relief discomfort associated with breast hypertrophy. Female breasts play an important role in sexuality, thus, the main purpose of this study is to determine whether reduction mammaplasty could influence sexual function and depression predictors on women with breast hypertrophy.

Official Title
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Sexuality and Depression Predictors Among Breast Hypertrophy Women Undergoing Reduction Mammaplasty

Conditions
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Sexual Function, Depression

Intervention / Treatment
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* Procedure: Reduction mammaplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: breast hypertrophy candidate to reduction mammaplasty healthy volunteer with normal volume breasts (control group) body mass index under 30Kg/m2 Exclusion Criteria: pregnancy, delivery or breast feeding during the last 12 months body mass index over 30Kg/m2 breast cancer history previous breast surgery hard smoking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Breast hypertrophy<br>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 | |
| Experimental: Reduction Mammaplasty<br>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 | Procedure: Reduction mammaplasty<br>* Sexual function of patients undergoing reduction mammaplasty will be assessed by the Female Sexual Function Index (FSFI) preoperatively and 3 and 6 months postoperatively.<br>* Other names: Breast reduction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual function | Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression predictors | Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast hypertrophy, mammaplasty, sexuality, depression