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Satisfaction, Pain and Function Outcomes of Breast Reduction Patients

Sponsor
Claytor Noone Plastic Surgery (Other)
Overall Status
Completed
CT.gov ID
NCT05288530
Collaborator
(none)
35
Enrollment
23
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    35 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Satisfaction, Pain and Function Outcomes of Breast Reduction Patients: A Retrospective Chart Review and Patient Follow up
    Actual Study Start Date :
    Oct 1, 2016
    Actual Primary Completion Date :
    Jun 1, 2018
    Actual Study Completion Date :
    Sep 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. DASH questionnaire [6 months]

      Disabilities of the arm shoulder and hand, pain and function indicators

    2. Breast Q questionnaire [6 months]

      quality of life questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 70 Years
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Claytor Noone Plastic Surgery

    Investigators

    • Principal Investigator: Brannon Claytor, Claytor Noone Plastic Surgery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Claytor Noone Plastic Surgery
    ClinicalTrials.gov Identifier:
    NCT05288530
    Other Study ID Numbers:
    • R17-3683B
    First Posted:
    Mar 21, 2022
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertrophy

    Study Results

    No Results Posted as of Mar 21, 2022