Reduction Mammaplasty and Improved Quality of Life (MammaRed)

May 11, 2016 updated by: Julius Hodosy, University Hospital Bratislava

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Bratislava, Slovakia, 82101
        • University Hospital Bratislava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 61 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females with macromastia undergoing elective reduction surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with macromasty
Female adult patients with symptomatic macromasty selected for elective reduction surgery
Procedure: Reduction mammaplasty
Surgical removal of excess breast tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 2000-2014
Questionnaires about quality of life before and up to 12 years after surgery
2000-2014

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of adverse outcomes
Time Frame: 2000-2014
Evaluation of rate and types of negative outcomes up to 12 years after elective reduction surgery
2000-2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Bratislava

Collaborators

Comenius University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • UHB/005/2015/MB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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