Reduction Mammaplasty and Improved Quality of Life

NCT ID: NCT02769559

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-31

Study Completion Date

2016-05-31

Brief Summary

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

Detailed Description

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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

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Macromastia Signs and Symptoms Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with macromasty

Female adult patients with symptomatic macromasty selected for elective reduction surgery

Reduction mammaplasty

Intervention Type PROCEDURE

Surgical removal of excess breast tissue

Interventions

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Reduction mammaplasty

Surgical removal of excess breast tissue

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

63 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Comenius University

OTHER

Sponsor Role collaborator

University Hospital Bratislava

OTHER

Sponsor Role lead

Responsible Party

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Julius Hodosy

Reduction mammaplasty safely increases the quality of life in patients with mammary hypetrophy.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Bratislava

Bratislava, , Slovakia

Site Status

Countries

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Slovakia

Other Identifiers

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UHB/005/2015/MB

Identifier Type: -

Identifier Source: org_study_id

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