An Observational Study Exploring the Esthetic Outcomes of Breast Reduction Surgery and /or Mastopexy

Study Overview
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Brief Summary
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The purpose of the study is to collect data regarding the aesthetic outcomes of patients who had breast reduction surgery and /or mastopexy in terms such as scaring, patient satisfaction, breast ptosis assessment including taking photographs and filling questionnaires.

Detailed Description
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This is a prospective observational study, single center cohort to explore the aesthetic outcomes of patients who had breast reduction and / or mastopxy surgery. The surgical intervention will be determined by the clinician with no correlation to this study. The study will focus on the aesthetic aspects of the clinical outcome resultant from the breast surgery in par course of 5 years. Scar tissue assessment and patient's reported data (satisfaction and well-being) will be collected. Suitable patients will be assessed for study eligibility at a screening visit and, if eligible, will be scheduled for breast surgery according to the patient and surgeon discretion. At each follow up visit, patients will undergo clinical general examination, breast and ptosis endearments, scar appearance , aesthetic evaluation. Patients will fill satisfaction questionnaires

Official Title
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An Observational Study Exploring the Esthetic Outcomes of Breast Reduction Surgery and /or Mastopexy

Conditions
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Macromastia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patient older than 30 years of age. Patients willing to participate as evidenced by signing the written informed consent. Patient that was found by her physician illegible for breast reduction surgery and /or mastopxy Exclusion Criteria: 1. Active psychiatric illness, cognitive or sensory impairment. 2. Physical impairment that may prevent filling out a paper and pencil survey or responding to interview questions -

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observation<br>no specific treatment. Long term observation the results of any breast lifting or reduction surgeries | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the aesthetic outcomes of pre /post- surgical breast ptosis | Breast measurements consists on: Breast cup size Distortions or skin retractions Symmetry between the two breasts Ptosis grade evaluated on the basis of an I-IV scale Methods to measure breast shape and symmetry Skin texture (soft or hard) Skin consistency Nipple location on the breast mound scored on a scale of 1 - 5 Areola diameter (mm) The shape of the breast scored on a scale of 1 - 5 Scar Appearance evaluation -VAS score Patient satisfaction questionnaires | during 5 years post- surgically | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast reduction, Mastopexy, Sagging