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Trial record 20 of 1645 for:    Slovakia

Reduction Mammaplasty and Improved Quality of Life (MammaRed)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02769559
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Comenius University
Information provided by (Responsible Party):
Julius Hodosy, 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.

Condition or disease Intervention/treatment
Macromastia Signs and Symptoms Quality of Life Procedure: Reduction mammaplasty

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.

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Reduction Mammaplasty Safely Increases the Quality of Life in Patients With Mammary Hypetrophy.
Study Start Date : January 2000
Actual Primary Completion Date : December 2014
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Quality of life [ Time Frame: 2000-2014 ]
    Questionnaires about quality of life before and up to 12 years after surgery


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 63 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Females with macromastia undergoing elective reduction surgery.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769559


Locations
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Slovakia
University Hospital Bratislava
Bratislava, Slovakia, 82101
Sponsors and Collaborators
University Hospital Bratislava
Comenius University

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Responsible Party: Julius Hodosy, Reduction mammaplasty safely increases the quality of life in patients with mammary hypetrophy., University Hospital Bratislava
ClinicalTrials.gov Identifier: NCT02769559     History of Changes
Other Study ID Numbers: UHB/005/2015/MB
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Signs and Symptoms