Breast HypertrophyNCT01297621
Physical Activity and Sexuality After Reduction Mammaplasty
A study testing reduction mammaplasty in people with Breast Hypertrophy, run by Daniela Francescato Veiga at 1 site in Brazil.
Trial summary
This prospective controlled trial was designed to determine whether breast reduction may influence physical activity and sexuality of breast hypertrophy women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Hypertrophy
- What is being tested?
- reduction mammaplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- May 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- breast hypertrophy
- candidate to reduction mammaplasty
- body mass index under 30Kg/m2
- women with sexual activity
Who cannot join
- pregnancy, delivery or breast feeding during the last 12 months
- body mass index over 30Kg/m2
- breast cancer history
- previous breast surgery
- smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Hypertrophy
- Being tested
- reduction mammaplasty, control
- Keywords
- breast hypertrophy, physical activity, sexuality, patient satisfaction
- Medical subject headings
- Gigantomastia, Motor Activity, Sexuality, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduction mammaplastyProcedure or surgery
conventional reduction mammaplasty
controlOther
follow up, questionnaire responses
| Study group | Role | What they receive |
|---|---|---|
| Breast reduction | Experimental | Breast hypertrophy women allocated to this arm will undergo reduction mammaplasty Receives: Procedure: reduction mammaplasty |
| Control | Other | Patients in this arm will be assessed twice, without surgical intervention Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (2)
Patient's satisfaction
Patient's satisfaction will be assessed after 6 months, by the Breast Evaluation Questionnaire
Measured: 6 months
Sexuality
Sexuality will be assessed by a brazilian validated questionnaire, the Female Sexual Quotient, at preoperative and sixth postoperative month
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startMay 2010
- Primary completionFeb 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniela Francescato Veiga
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniela Francescato Veiga, Federal University of São Paulo
- Investigators
- Vanessa L Resende, MD, Principal investigator, Federal University of São PauloMiguel Sabino-Neto, MD, PhD, Study director, Federal University of São PauloDaniela F Veiga, MD, PhD, Study director, Federal University of São PauloLydia M Ferreira, MD, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297621
- Sponsor's protocol ID
- Mestre 1
- Other IDs
- 0651/10
- Status last verified
- Jul 2013
- First submitted
- 16 Feb 2011
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction, Physical Activity and Sexuality Outcomes in Breast Reduction Patients
- ClinicalTrials.gov ID
- NCT01297621
- Acronym / sponsor ID
- Mestre 1
- Conditions
- Breast Hypertrophy
- Keywords
- breast hypertrophy, physical activity, sexuality, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Daniela Francescato VeigaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective controlled trial was designed to determine whether breast reduction may influence physical activity and sexuality of breast hypertrophy women.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast reduction | Experimental | Procedure: reduction mammaplastyBreast hypertrophy women allocated to this arm will undergo reduction mammaplasty |
| Control | Other | Other: controlPatients in this arm will be assessed twice, without surgical intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- breast hypertrophy
- candidate to reduction mammaplasty
- body mass index under 30Kg/m2
- women with sexual activity
Key exclusion criteria (5 listed)
- pregnancy, delivery or breast feeding during the last 12 months
- body mass index over 30Kg/m2
- breast cancer history
- previous breast surgery
- smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reduction mammaplastyconventional reduction mammaplasty | Procedure or surgery | Breast reduction |
| controlfollow up, questionnaire responses | Other | Control |
Primary outcome
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
2 secondary outcomes
Patient's satisfaction
Time frame: 6 months
Sexuality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa L Resende, MD principal investigator
Federal University of São Paulo
Miguel Sabino-Neto, MD, PhD study director
Federal University of São Paulo
Daniela F Veiga, MD, PhD study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reduction mammaplasty in people with Breast Hypertrophy, run by Daniela Francescato Veiga at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical activity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2013.