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Physical Activity and Sexuality After Reduction Mammaplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01297621
First Posted: February 17, 2011
Last Update Posted: July 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniela Francescato Veiga, Federal University of São Paulo
  Purpose
This prospective controlled trial was designed to determine whether breast reduction may influence physical activity and sexuality of breast hypertrophy women.

Condition Intervention
Breast Hypertrophy Procedure: reduction mammaplasty Other: control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Satisfaction, Physical Activity and Sexuality Outcomes in Breast Reduction Patients

Resource links provided by NLM:


Further study details as provided by Daniela Francescato Veiga, Federal University of São Paulo:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Patient's satisfaction [ Time Frame: 6 months ]
    Patient's satisfaction will be assessed after 6 months, by the Breast Evaluation Questionnaire

  • Sexuality [ Time Frame: 6 months ]
    Sexuality will be assessed by a brazilian validated questionnaire, the Female Sexual Quotient, at preoperative and sixth postoperative month


Estimated Enrollment: 60
Study Start Date: May 2010
Study Completion Date: June 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breast reduction
Breast hypertrophy women allocated to this arm will undergo reduction mammaplasty
Procedure: reduction mammaplasty
conventional reduction mammaplasty
Control
Patients in this arm will be assessed twice, without surgical intervention
Other: control
follow up, questionnaire responses

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297621


Locations
Brazil
Hospital São Paulo
São Paulo, SP, Brazil, 04024002
Sponsors and Collaborators
Daniela Francescato Veiga
Investigators
Principal Investigator: Vanessa L Resende, MD Federal University of São Paulo
Study Director: Miguel Sabino-Neto, MD, PhD Federal University of São Paulo
Study Director: Daniela F Veiga, MD, PhD Federal University of São Paulo
Study Chair: Lydia M Ferreira, MD, PhD Federal University of São Paulo
  More Information

Responsible Party: Daniela Francescato Veiga, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01297621     History of Changes
Other Study ID Numbers: Mestre 1
0651/10 ( Other Identifier: Ethical Commitee )
First Submitted: February 16, 2011
First Posted: February 17, 2011
Last Update Posted: July 9, 2013
Last Verified: July 2013

Keywords provided by Daniela Francescato Veiga, Federal University of São Paulo:
breast hypertrophy
physical activity
sexuality
patient satisfaction

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical