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

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.

Study Overview

• Status: Terminated
• Conditions: Macromastia

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • The Plastic Surgery Department The Tel Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female Patients, 30 years of age or older referred for elective breast reduction surgery and /or mastopxy

Description

Inclusion Criteria:

1. Female patient older than 30 years of age.
2. Patients willing to participate as evidenced by signing the written informed consent.
3. 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

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
observation; no specific treatment. Long term observation the results of any breast lifting or reduction surgeries

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Orbix Medical Ltd.
• Investigators: Study Director: Arik Zaretski, MD, TASMC

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 15, 2013
• First Posted (ESTIMATE): December 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 23, 2015
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Mastopexy; Breast reduction; Sagging
• Other Study ID Numbers: CLI-02