Physical Activity and Sexuality After Reduction Mammaplasty

Study Overview
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Brief Summary
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This prospective controlled trial was designed to determine whether breast reduction may influence physical activity and sexuality of breast hypertrophy women.

Detailed Description
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Breast hypertrophy is a frequent condition among women; reduction mammaplasty is one of the most performed procedures in plastic surgery.Previous studies have demonstrated that breast hypertrophy is associated to back pain, and patients often complain about physical limitations due to this condition, as well as sexual impairment. Thus, this trial was designed to test the hypothesis that reduction mammaplasty may improve physical and sexual performance of breast hypertrophy patients,and patients'satisfaction with the results of the operation. Three validated tools were used: the International Physical Activity Questionnaire (IPAQ), the Female Sexual Quotient and the Breast Evaluation Questionnaire.

Official Title
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Satisfaction, Physical Activity and Sexuality Outcomes in Breast Reduction Patients

Conditions
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Breast Hypertrophy

Intervention / Treatment
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* Procedure: reduction mammaplasty
* Other: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: breast hypertrophy candidate to reduction mammaplasty body mass index under 30Kg/m2 women with sexual activity Exclusion Criteria: pregnancy, delivery or breast feeding during the last 12 months body mass index over 30Kg/m2 breast cancer history previous breast surgery smoking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast reduction<br>Breast hypertrophy women allocated to this arm will undergo reduction mammaplasty | Procedure: reduction mammaplasty<br>* conventional reduction mammaplasty<br>|
| Other: Control<br>Patients in this arm will be assessed twice, without surgical intervention | Other: control<br>* follow up, questionnaire responses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity | Physical activity will be assessed by a validated instrument, the International Physical Activity Questionnaire (IPAQ), at pre-operative and 6 months after breast reduction | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction | Patient's satisfaction will be assessed after 6 months, by the Breast Evaluation Questionnaire | 6 months | 
| Sexuality | Sexuality will be assessed by a brazilian validated questionnaire, the Female Sexual Quotient, at preoperative and sixth postoperative month | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast hypertrophy, physical activity, sexuality, patient satisfaction