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| ID | Type | Description | Link |
|---|---|---|---|
| 0651/10 | Other Identifier | Ethical Commitee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast reduction | Experimental | Breast hypertrophy women allocated to this arm will undergo reduction mammaplasty |
|
| Control | Other | Patients in this arm will be assessed twice, without surgical intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reduction mammaplasty | Procedure | conventional reduction mammaplasty |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa L Resende, MD | Federal University of São Paulo | Principal Investigator |
| Miguel Sabino-Neto, MD, PhD | Federal University of São Paulo | Study Director |
| Daniela F Veiga, MD, PhD | Federal University of São Paulo | Study Director |
| Lydia M Ferreira, MD, PhD | Federal University of São Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital São Paulo | São Paulo | São Paulo | 04024002 | Brazil |
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| ID | Term |
|---|---|
| C536821 | Gigantomastia |
| D009043 | Motor Activity |
| D019529 | Sexuality |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012725 | Sexual Behavior |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| control |
| Other |
follow up, questionnaire responses |
|
| 6 months |