Reduction Mammaplasty and Improved Quality of Life

Quality of Life Clinical Trial

— MammaRed  

Official title:

Reduction Mammaplasty Safely Increases the Quality of Life in Patients With Mammary Hypetrophy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769559
• Other study ID #: UHB/005/2015/MB
• Status: Completed
• Phase: N/A
• First received: May 10, 2016
• Last updated: May 11, 2016
• Start date: January 2000
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University Hospital Bratislava
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The data gathered here will be used to evaluate the efficacy and safety of the mammary reduction in patients with macromastia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 63 Years

Eligibility

Inclusion Criteria:

• above 18 years

• macromastia on clinical examination

• fulfilled Breast Q Questionnaire prior to surgery and after surgery

• signed informed consent

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Macromastia
• Quality of Life
• Signs and Symptoms

Intervention

Procedure:
• Reduction mammaplasty
Surgical removal of excess breast tissue

Locations

Country	Name	City	State
Slovakia	University Hospital Bratislava	Bratislava

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Bratislava	Comenius University

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Questionnaires about quality of life before and up to 12 years after surgery	2000-2014	No
Secondary	Rate of adverse outcomes	Evaluation of rate and types of negative outcomes up to 12 years after elective reduction surgery	2000-2014	Yes