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OpenTrials
Completed

NCT Number: NCT02769559

Reduction Mammaplasty and Improved Quality of Life

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

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Key information

Conditions

Macromastia Gigantomastia Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms

Age range

18 year–63 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Bratislava

Bratislava, 82101, Slovakia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reduction mammaplasty

Procedure

Surgical removal of excess breast tissue

Primary outcomes

  1. Quality of life

    Time frame: 2000-2014

    Questionnaires about quality of life before and up to 12 years after surgery

Secondary outcomes

  1. Rate of adverse outcomes

    Time frame: 2000-2014

    Evaluation of rate and types of negative outcomes up to 12 years after elective reduction surgery

Sponsors and collaborators

Lead sponsor

University Hospital Bratislava

Other

Collaborators

  • Comenius University

Registry information

Official study title

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

Acronym: MammaRed

Important dates

Study start
2000
Primary completion
2014
Study completion
2016
First posted
May 11, 2016
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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