Physical Activity and Sexuality After Reduction Mammaplasty

Not Applicable

Completed

• Conditions: Breast Hypertrophy
• Interventions: Procedure: reduction mammaplasty; Other: control

• Registration Number: NCT01297621
• Lead Sponsor: Daniela Francescato Veiga

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-17
• Primary Completion: 2013-02
• Study Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-05
• Last Update Posted: 2013-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast reduction	reduction mammaplasty	Breast hypertrophy women allocated to this arm will undergo reduction mammaplasty
Control	control	Patients in this arm will be assessed twice, without surgical intervention

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient's satisfaction	6 months	Patient's satisfaction will be assessed after 6 months, by the Breast Evaluation Questionnaire
Sexuality	6 months	Sexuality will be assessed by a brazilian validated questionnaire, the Female Sexual Quotient, at preoperative and sixth postoperative month

Trial Locations

Locations (1)

Hospital São Paulo; 🇧🇷 São Paulo, SP, Brazil