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| Sponsors and Collaborators: |
Hamilton Health Sciences Canadian Society of Plastic Surgeons |
| Information provided by: | Hamilton Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00149344 |
Purpose
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 | Intervention |
|
Breast Hypertrophy |
Procedure: Vertical scar versus inferior pedicle reduction mammoplasty |
| MedlinePlus related topics: | Breast Reconstruction Scars |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty: A Randomized Controlled Trial and Cost-Utility Analysis |
| Estimated Enrollment: | 240 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | September 2008 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
If another procedure is to be “piggy backed’ to the reduction mammoplasty (e.g. liposuction to breast or elsewhere, abdominoplasty, etc)
(The surgeon will explain this principle only to those patients where there is uncertainty whether the resection will exceed 1000 grams. For the rest of the patients this is not necessary.)
Contacts and Locations| Canada, Ontario | |||||
| St. Joseph's Healthcare | Recruiting | ||||
| Hamilton, Ontario, Canada, L8N 4A6 | |||||
| Contact: Achilleas Thoma, MD MSc FRCSC 905-523-0019 athoma@mcmaster.ca | |||||
| Contact: Leslie McKnight, MSc 905-522-1155 ext 35877 mcknig@mcmaster.ca | |||||
| Principal Investigator: Achilleas Thoma, MD,MSC,FRCSC | |||||
| Hamilton Health Sciences |
| Canadian Society of Plastic Surgeons |
| Principal Investigator: | Achilleas Thoma, MD MSc FRCSC | McMaster University / St. Joseph's Healthcare |
More Information
| Study ID Numbers: | 05-2447 |
| First Received: | September 6, 2005 |
| Last Updated: | April 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00149344 |
| Health Authority: | Canada: Ethics Review Committee |
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