MammaRed: Reduction Mammaplasty and Improved Quality of Life

• Sponsor: University Hospital Bratislava (Other)
• Overall Status: Completed
• CT.gov ID: NCT02769559
• Collaborator: Comenius University (Other)
• Enrollment: 52
• Location: 1
• Duration (Months): 196
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Jan 1, 2000
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Quality of life [2000-2014]

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

Secondary Outcome Measures

1. Rate of adverse outcomes [2000-2014]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 63 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Bratislava	Bratislava		Slovakia	82101

Sponsors and Collaborators

• University Hospital Bratislava
• Comenius University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Julius Hodosy, Reduction mammaplasty safely increases the quality of life in patients with mammary hypetrophy., University Hospital Bratislava
• ClinicalTrials.gov Identifier: NCT02769559
• Other Study ID Numbers: UHB/005/2015/MB
• First Posted: May 11, 2016
• Last Update Posted: May 12, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of May 12, 2016