MacromastiaMammaRedNCT02769559
Reduction Mammaplasty and Improved Quality of Life
An observational study of Macromastia and Signs and Symptoms, run by University Hospital Bratislava at 1 site in Slovakia.
Trial summary
The data gathered here will be used to evaluate the efficacy and safety of the mammary reduction in patients with macromastia. Read more about this study
- Who is it for?
- Ages 18 to 63 years, women only
- Conditions the study is for
- Macromastia, Signs and Symptoms, Quality of Life
- What is being tested?
- Reduction mammaplasty
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteSlovakia
- Study dates
- Jan 2000to May 2016
- Phase
- Observational
- 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 63 years
- Women only
- No healthy volunteers
- Adult
Study population: Females with macromastia undergoing elective reduction surgery.
Who may be able to join
- above 18 years
- macromastia on clinical examination
- fulfilled Breast Q Questionnaire prior to surgery and after surgery
- signed informed consent
Who cannot join
- failed to sign informed consent
- failed to fill the Breast Q Questionnaire
- patients with altered mental status and behaviour
- patients with concomitant breast disease, or with previous breast interventions as are radiotherapy, surgery, or breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction Mammaplasty Safely Increases the Quality of Life in Patients With Mammary Hypetrophy.
The data gathered here will be used to evaluate the efficacy and safety of the mammary reduction in patients with macromastia.
Read the detailed description
The data was gathered using retrospective and follow-up prospective study of a group of patients, consisting of adult women that underwent a breast reduction surgery at the Clinic of Plastic, Reconstructive and Aesthetic Surgery Faculty of Comenius University and at the University Hospital in Bratislava, Ružinov, during the time period between 2000 until May 2014. The data concerning the quality of life of these patients was gathered by using the globally standardized questionnaire "Breast Q questionnaire©" with the separate software system evaluation tool "QScore©". The statistical analysis was conducted using GraphpadPrism program v. 6.01. The total number of respondents consisted of 52 people who were followed-up for up to 12 years.
- Conditions
- Macromastia, Signs and Symptoms, Quality of Life
- Being tested
- Reduction mammaplasty
- Medical subject headings
- Gigantomastia, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction mammaplastyProcedure or surgery
Surgical removal of excess breast tissue
| Study group | Role | What they receive |
|---|---|---|
| Patients with macromasty | Female adult patients with symptomatic macromasty selected for elective reduction surgery Receives: Procedure: Reduction mammaplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Questionnaires about quality of life before and up to 12 years after surgery
Measured: 2000-2014
Secondary outcomes (1)
Rate of adverse outcomes
Evaluation of rate and types of negative outcomes up to 12 years after elective reduction surgery
Measured: 2000-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJan 2000
- Primary completionDec 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MacromastiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bratislava
- Sponsor type
- University, hospital or other
- Collaborators
- Comenius University
- Responsible party
- Principal investigator, Julius Hodosy, University Hospital Bratislava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769559
- Sponsor's protocol ID
- UHB/005/2015/MB
- Acronym
- MammaRed
- Status last verified
- May 2016
- First submitted
- 10 May 2016
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction Mammaplasty Safely Increases the Quality of Life in Patients With Mammary Hypetrophy.
- ClinicalTrials.gov ID
- NCT02769559
- Acronym / sponsor ID
- MammaRed / UHB/005/2015/MB
- Conditions
- Macromastia, Signs and Symptoms, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital BratislavaUniversity, hospital or other
- Collaborators
- Comenius University
- Study start
- Jan 2000
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 May 2016 (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.
The data gathered here will be used to evaluate the efficacy and safety of the mammary reduction in patients with macromastia.
Detailed description
The data was gathered using retrospective and follow-up prospective study of a group of patients, consisting of adult women that underwent a breast reduction surgery at the Clinic of Plastic, Reconstructive and Aesthetic Surgery Faculty of Comenius University and at the University Hospital in Bratislava, Ružinov, during the time period between 2000 until May 2014. The data concerning the quality of life of these patients was gathered by using the globally standardized questionnaire "Breast Q questionnaire©" with the separate software system evaluation tool "QScore©". The statistical analysis was conducted using GraphpadPrism program v. 6.01. The total number of respondents consisted of 52 people who were followed-up for up to 12 years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with macromasty | – | Procedure: Reduction mammaplastyFemale adult patients with symptomatic macromasty selected for elective reduction surgery |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Females with macromastia undergoing elective reduction surgery.
Key inclusion criteria (4 listed)
- above 18 years
- macromastia on clinical examination
- fulfilled Breast Q Questionnaire prior to surgery and after surgery
- signed informed consent
Key exclusion criteria (4 listed)
- failed to sign informed consent
- failed to fill the Breast Q Questionnaire
- patients with altered mental status and behaviour
- patients with concomitant breast disease, or with previous breast interventions as are radiotherapy, surgery, or breast cancer
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 mammaplastySurgical removal of excess breast tissue | Procedure or surgery | Patients with macromasty |
Primary outcome
Quality of life
Time frame: 2000-2014
Questionnaires about quality of life before and up to 12 years after surgery
1 secondary outcome
Rate of adverse outcomes
Time frame: 2000-2014
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 12 May 2016.
- Individual participant dataSharing planned: No
Related trials for Macromastia
Recruiting
Improved Breast Enlargement Using the Subject's Own Fat Tissue
Breast Augmentation
Recruiting
ESPB Versus Intravenous Lidocaine for Pain After Mastopexy
Breast Hypertrophy
RecruitingPhase 4
Pectoral Block in Breast Reduction for Pain Control
Macromastia (Symptomatic)
Recruiting
NPWT Reduction Mammaplasty
Healthy, Macromastia
RecruitingObservational study
Indications for Breast Reduction in the Public Health Care System
Mammary Gland Hyperplasia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macromastia and Signs and Symptoms, run by University Hospital Bratislava at 1 site in Slovakia.
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 4 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 12 May 2016. 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 Slovakia. 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?
Quality of life (time frame: 2000-2014). 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 12 May 2016.