- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05288530
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
Conditions
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.
Sponsor
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.
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