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Physical Activity and Sexuality After Reduction Mammaplasty

This study has been completed.
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 5, 2013
Last verified: July 2013

February 16, 2011
July 5, 2013
May 2010
February 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01297621 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Physical Activity and Sexuality After Reduction Mammaplasty
Satisfaction, Physical Activity and Sexuality Outcomes in Breast Reduction Patients

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Breast Hypertrophy
  • Procedure: reduction mammaplasty
    conventional reduction mammaplasty
  • Other: control
    follow up, questionnaire responses
  • Experimental: Breast reduction
    Breast hypertrophy women allocated to this arm will undergo reduction mammaplasty
    Intervention: Procedure: reduction mammaplasty
  • Control
    Patients in this arm will be assessed twice, without surgical intervention
    Intervention: Other: control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2013
February 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01297621
Mestre 1, 0651/10
No
Daniela Francescato Veiga, Federal University of São Paulo
Daniela Francescato Veiga
Not Provided
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
Federal University of São Paulo
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP