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Completed

NCT Number: NCT01297621

Physical Activity and Sexuality After Reduction Mammaplasty

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

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Key information

Conditions

Breast Hypertrophy Behavior Gigantomastia Health Behavior Motor Activity Patient Satisfaction Sexual Behavior Sexuality Treatment Adherence and Compliance

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital São Paulo

São Paulo, 04024002, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reduction mammaplasty

Procedure

conventional reduction mammaplasty

Control

Other

follow up, questionnaire responses

Primary outcomes

  1. physical activity

    Time frame: 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 outcomes

  1. Patient's satisfaction

    Time frame: 6 months

    Patient's satisfaction will be assessed after 6 months, by the Breast Evaluation Questionnaire

  2. Sexuality

    Time frame: 6 months

    Sexuality will be assessed by a brazilian validated questionnaire, the Female Sexual Quotient, at preoperative and sixth postoperative month

Sponsors and collaborators

Lead sponsor

Daniela Francescato Veiga

Other

Registry information

Official study title

Satisfaction, Physical Activity and Sexuality Outcomes in Breast Reduction Patients

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 17, 2011
Registry last updated
Jul 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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