Physical Activity and Sexuality After Reduction Mammaplasty

Breast Hypertrophy Clinical Trial

Official title:

Satisfaction, Physical Activity and Sexuality Outcomes in Breast Reduction Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297621
• Other study ID #: Mestre 1
• Secondary ID: 0651/10
• Status: Completed
• Phase: N/A
• First received: February 16, 2011
• Last updated: July 5, 2013
• Start date: May 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Hypertrophy
• Hypertrophy

Intervention

Procedure:
• reduction mammaplasty
conventional reduction mammaplasty

Other:
• control
follow up, questionnaire responses

Locations

Country	Name	City	State
Brazil	Hospital São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Daniela Francescato Veiga

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient's satisfaction	Patient's satisfaction will be assessed after 6 months, by the Breast Evaluation Questionnaire	6 months	No
Secondary	Sexuality	Sexuality will be assessed by a brazilian validated questionnaire, the Female Sexual Quotient, at preoperative and sixth postoperative month	6 months	No