Breast Hypertrophy Clinical Trial
Official title:
A Prospective Study of Patients Undergoing Breast Reduction Surgery: Health-Related Quality of Life and Clinical Outcomes
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.
This study addresses the following questions of clinical and policy relevance: 1) Is the pre-surgery HRQL of these patients compromised and, if so, in which areas? 2) Do patients’ HRQL improve after surgery and, if so, when and in which areas and by how much? 3) Is there a relationship between BMI and pre-/post-surgery changes in HRQL (i.e., is the pre/post effect similar for both obese and non-obese patients)? and 4) Is there a relationship between tissue re-section weight and pre-/post-surgery changes in HRQL (i.e., is the pre/post HRQL effect similar for patients having small and large amounts of tissue resected)? ;
Observational Model: Defined Population, Time Perspective: Longitudinal
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