Physical Activity and Sexuality After Reduction Mammaplasty

NCT ID: NCT01297621

Last Updated: 2013-07-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-06-30

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.

Conditions

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Breast Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Breast reduction

Breast hypertrophy women allocated to this arm will undergo reduction mammaplasty

Group Type EXPERIMENTAL

reduction mammaplasty

Intervention Type PROCEDURE

conventional reduction mammaplasty

Control

Patients in this arm will be assessed twice, without surgical intervention

Group Type OTHER

control

Intervention Type OTHER

follow up, questionnaire responses

Interventions

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reduction mammaplasty

conventional reduction mammaplasty

Intervention Type PROCEDURE

control

follow up, questionnaire responses

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Daniela Francescato Veiga

OTHER

Sponsor Role lead

Responsible Party

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Daniela Francescato Veiga

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Vanessa L Resende, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Miguel Sabino-Neto, MD, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Daniela F Veiga, MD, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Lydia M Ferreira, MD, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

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Hospital São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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0651/10

Identifier Type: OTHER

Identifier Source: secondary_id

Mestre 1

Identifier Type: -

Identifier Source: org_study_id

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