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Physical Activity and Sexuality After Reduction Mammaplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Daniela Francescato Veiga, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01297621
First received: February 16, 2011
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  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: Open Label
Official Title: Satisfaction, Physical Activity and Sexuality Outcomes in Breast Reduction Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patient's satisfaction will be assessed after 6 months, by the Breast Evaluation Questionnaire

  • Sexuality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 16, 2011
Last Updated: July 23, 2012
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013