NCT00149344

Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty

Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty: A Randomized Controlled Trial and Cost-Utility Analysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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 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.

Conditions

• Breast Hypertrophy

Interventions

Type	Name	Description
RADIATION	Vertical scar versus inferior pedicle reduction mammoplasty	Vertical Scar Reduction Mammoplasty Inferior Pedicle Reduction Mammoplasty

Timeline

• Start date: 2005-09-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2005-09-08
• Last updated: 2011-07-28

Locations

1 site across 1 country: Canada