Satisfaction, Pain and Function Outcomes of Breast Reduction Patients

March 10, 2022 updated by: Claytor Noone Plastic Surgery

Satisfaction, Pain and Function Outcomes of Breast Reduction Patients: A Retrospective Chart Review and Patient Follow up

To explore the indications and benefits of breast reduction. The investigators suspect all of the patients in this population suffer from neck/back pain and limitations in function. The investigators also want to review the patients in this group to determine if the amount of breast tissue removed or previous breast size affects outcomes for these patients. Patients will then be contacted for outcome data and satisfaction information. Ultimately, this information may lead to improvements in management and education of patients with macromastia.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

35

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females age 21-70 with a diagnosis of hypertrophy of the breast who underwent surgical intervention

Description

Inclusion Criteria:

  • Females
  • Ages 21-71 years-old
  • Hypertropy of the breast
  • Macromastia
  • post-surgical intervention for macromastia or hypertrophy of the breast

Exclusion Criteria:

  • Males
  • BMI>40
  • Hypertrophy of the breast but without surgical intervention
  • Macromastia but without surgical intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH questionnaire
Time Frame: 6 months
Disabilities of the arm shoulder and hand, pain and function indicators
6 months
Breast Q questionnaire
Time Frame: 6 months
quality of life questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Brannon Claytor, Claytor Noone Plastic Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

September 1, 2018

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

March 10, 2022

First Posted (ACTUAL)

March 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R17-3683B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Macromastia

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