Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00149344
Status:
COMPLETED
Last Update Posted:
2011-07-28
First Post:
2005-09-06
Brief Title:
Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty A Randomized Controlled Trial and Cost-Utility Analysis
Status:
COMPLETED
Status Verified Date:
2011-07
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:
Main research question Is vertical scar reduction mammoplasty superior when compared to inferior pedicle reduction mammoplasty in terms of patient quality of life and cost-effectiveness
Why is this research important There is on-going controversy among plastic surgeons as to the superiority of one technique vertical scar mammoplasty versus inferior pedicle reduction mammoplasty over the other in terms of patient health related quality of life and health care resource utilization
What is being studied We are studying comparing two surgical procedures for breast reduction mammoplasty vertical scar mammoplasty versus inferior pedicle reduction mammoplasty
Why is this research important There is on-going controversy among plastic surgeons as to the superiority of one technique vertical scar mammoplasty versus inferior pedicle reduction mammoplasty over the other in terms of patient health related quality of life and health care resource utilization
What is being studied We are studying comparing two surgical procedures for breast reduction mammoplasty vertical scar mammoplasty versus inferior pedicle reduction mammoplasty
Detailed Description:
Breast reduction is one of the most common procedures performed by plastic surgeons Because it is common and in most jurisdictions requires at least one day of hospital stay it consumes considerable health care resources Although multiple techniques have been reported the two top competing techniques used in North America are the inferior pedicle technique and the vertical scar technique There is on-going controversy as to the superiority of one technique over the other in terms of patient satisfaction and health care resource utilization In the last few years third party payers have been concerned with the unnecessary consumption of scarce health care resources due to the variation of practice mostly influenced by surgeon preferences rather than valid evidence
The purpose of this study is to test the hypothesis that Vertical Scar Reduction Mammoplasty VSR is superior to the Inferior Pedicle Reduction Mammoplasty IPR in terms of patient health-related quality of life HRQL Health related quality of life will be measured by the Health Utilities Index Mark 23 HUI providing the outcome quality adjusted life years QALYs and the Breast Reduction Assessment Value and Outcomes BRAVO instruments The BRAVO instruments consist of a set of separate instruments including the Short Form 36 SF-36 the Multidimensional Body Self Relations Questionnaire Appearance Assessment MBSRQ-AS and the Breast Related Symptoms Questionnaire BRSQ The MBSRQ-AS provides a measure of self-evaluation of appearance and the BRSQ measures the breast symptom score Secondly we will test whether the VSR is a more cost-effective procedure If the hypothesis is confirmed that the VSR technique is more cost-effective then there will be compelling evidence to adopt it Regardless of whether VSR is found to be cost-effective the plastic surgery community third party payers and patients will be informed about the results
The purpose of this study is to test the hypothesis that Vertical Scar Reduction Mammoplasty VSR is superior to the Inferior Pedicle Reduction Mammoplasty IPR in terms of patient health-related quality of life HRQL Health related quality of life will be measured by the Health Utilities Index Mark 23 HUI providing the outcome quality adjusted life years QALYs and the Breast Reduction Assessment Value and Outcomes BRAVO instruments The BRAVO instruments consist of a set of separate instruments including the Short Form 36 SF-36 the Multidimensional Body Self Relations Questionnaire Appearance Assessment MBSRQ-AS and the Breast Related Symptoms Questionnaire BRSQ The MBSRQ-AS provides a measure of self-evaluation of appearance and the BRSQ measures the breast symptom score Secondly we will test whether the VSR is a more cost-effective procedure If the hypothesis is confirmed that the VSR technique is more cost-effective then there will be compelling evidence to adopt it Regardless of whether VSR is found to be cost-effective the plastic surgery community third party payers and patients will be informed about the results
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