Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty

This study has been completed.
Sponsor:
Collaborator:
Canadian Society of Plastic Surgeons
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00149344
First received: September 6, 2005
Last updated: July 27, 2011
Last verified: July 2011

September 6, 2005
July 27, 2011
September 2005
July 2011   (final data collection date for primary outcome measure)
Health related quality of life (utilities and disease specific) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Health related quality of life (utilities and disease specific) and health care resource utilization as well as out-of-pocket expenses by patients and caregivers.
Complete list of historical versions of study NCT00149344 on ClinicalTrials.gov Archive Site
Health care resource utilization as well as out-of-pocket expenses by patients and caregivers. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Adverse events
Not Provided
Not Provided
 
Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty
Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty: A Randomized Controlled Trial and Cost-Utility Analysis

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Breast Hypertrophy
Radiation: Vertical scar versus inferior pedicle reduction mammoplasty
Vertical Scar Reduction Mammoplasty Inferior Pedicle Reduction Mammoplasty
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
254
July 2011
July 2011   (final data collection date for primary outcome measure)

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.)

Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00149344
05-2447
No
Dr. Achilleas Thoma, McMaster University
McMaster University
Canadian Society of Plastic Surgeons
Principal Investigator: Achilleas Thoma, MD MSc FRCSC McMaster University / St. Joseph's Healthcare
McMaster University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP