Breast Hypertrophy Clinical Trial
Official title:
A Prospective Study of Patients Undergoing Breast Reduction Surgery: Health-Related Quality of Life and Clinical Outcomes
Verified date | August 2005 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Observational |
Despite the growing evidence showing that breast hypertrophy is associated with reduced
Health-Related Quality of Life (HRQL) and that reduction mammoplasty has a significant
positive impact on HRQL, there are unresolved issues that need to be addressed. These
include our ability to measure quantitatively the change that occurs after reduction and the
ongoing restriction or denials of third party payments based on body mass index (BMI). The
primary purpose of this study is to assess and measure the HRQL experienced by breast
reduction patients using four reliable and validated HRQL measures.
Fifty-two consecutive patients with the diagnosis of breast hypertrophy were invited to
participate in this prospective study. Participants completed the Health Utilities Index
Mark 2 (HUI2) and Mark 3 (HUI3) and the Breast Reduction Assessment Value and Outcomes
(BRAVO) instruments (the Short Form 36, the Multidimensional Body-Self Rating Questionnaire
Appearance Assessment, and the Breast Related Symptom Questionnaire) at one week and one day
pre-surgery and one, six, and 12 months post-surgery.
Status | Completed |
Enrollment | 52 |
Est. completion date | August 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of breast hypertrophy - Government approval for payment of reduction mammoplasty Exclusion Criteria: - Unable or unwilling to complete the quality of life questionnaires |
Observational Model: Defined Population, Time Perspective: Longitudinal
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Healthcare / McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation |
Canada,
Thoma A, Sprague S, Veltri K, Duku E, Furlong W. Methodology and measurement properties of health-related quality of life instruments: a prospective study of patients undergoing breast reduction surgery. Health Qual Life Outcomes. 2005 Jul 22;3:44. — View Citation
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