Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty
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|ClinicalTrials.gov Identifier: NCT00149344|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : July 28, 2011
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).
|Condition or disease||Intervention/treatment|
|Breast Hypertrophy||Radiation: Vertical scar versus inferior pedicle reduction mammoplasty|
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 2/3 (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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||254 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty: A Randomized Controlled Trial and Cost-Utility Analysis|
|Study Start Date :||September 2005|
|Primary Completion Date :||July 2011|
|Study Completion Date :||July 2011|
Radiation: Vertical scar versus inferior pedicle reduction mammoplasty
- Health related quality of life (utilities and disease specific) [ Time Frame: 1 Year ]
- Health care resource utilization as well as out-of-pocket expenses by patients and caregivers. [ Time Frame: 1 Year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149344
|St. Joseph's Healthcare|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Achilleas Thoma, MD MSc FRCSC||McMaster University / St. Joseph's Healthcare|