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Completed

NCT Number: NCT00149344

Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suffering from breast hypertrophy
  • Patients who received OHIP approval for reduction mammoplasty
  • Candidate for both surgical procedures
  • Patient is willing to complete quality of life questionnaires and follow up
  • Patient will provide informed consent

Exclusion criteria

  • Unilateral Breast Hypertrophy
  • Patients under the age of 18 years
  • Inability to complete questionnaires due to language problems
  • Bilateral mastopexy (breast lift)
  • Previous breast reduction surgery
  • Patients who will require greater than 1000 grams to be removed from either breast (to be assessed by the Archimedes principle* preoperatively; patients who by the Archimedes principle displace 1400 cc of volume will be excluded from the study)
  • Pre-operative radiation after lumpectomy
  • If another procedure is to be "piggy backed' to the reduction mammoplasty (e.g. liposuction to breast or elsewhere, abdominoplasty, etc)
  • The Archimedes principle is as follows: In the privacy of her bathroom the patient will immerse each breast separately into a large pot filled to the brim with tap water. The breast will displace some of the water which will be collected into another larger container e.g. plastic dish pan placed underneath the pot. The patient will be asked to measure the volume of the displaced water in ml. The volume that will be displaced will approximate the weight of the breast. The measurement will be done 3 times and the average for each breast will be recorded.

(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.)

Treatment and study plan

Vertical scar versus inferior pedicle reduction mammoplasty

Radiation

Vertical Scar Reduction Mammoplasty Inferior Pedicle Reduction Mammoplasty

Primary outcomes

  1. Health related quality of life (utilities and disease specific)

    Time frame: 1 Year

Secondary outcomes

  1. Health care resource utilization as well as out-of-pocket expenses by patients and caregivers.

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Society of Plastic Surgeons

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Sep 8, 2005
Registry last updated
Jul 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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