Reduction Mammaplasty and Improved Quality of Life

Completed

• Conditions: Macromastia; Signs and Symptoms; Quality of Life
• Interventions: Procedure: Reduction mammaplasty

• Registration Number: NCT02769559
• Lead Sponsor: University Hospital Bratislava

Brief Summary

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 Timeline

• Study Start: 2000-01
• Primary Completion: 2014-12
• Status Verified: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with macromasty	Reduction mammaplasty	Female adult patients with symptomatic macromasty selected for elective reduction surgery

Primary Outcome Measures

Name	Time	Method
Quality of life	2000-2014	Questionnaires about quality of life before and up to 12 years after surgery

Secondary Outcome Measures

Name	Time	Method
Rate of adverse outcomes	2000-2014	Evaluation of rate and types of negative outcomes up to 12 years after elective reduction surgery

Trial Locations

Locations (1)

University Hospital Bratislava; 🇸🇰 Bratislava, Slovakia