Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00149370
Status:
COMPLETED
Last Update Posted:
2005-09-08
First Post:
2005-09-06
Brief Title:
Quality of Life Among Breast Reduction Patients
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
A Prospective Study of Patients Undergoing Breast Reduction Surgery Health-Related Quality of Life and Clinical Outcomes
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 ie is the prepost 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 ie is the prepost HRQL effect similar for patients having small and large amounts of tissue resected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None