Status:
COMPLETED
Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Society of Plastic Surgeons
Conditions:
Breast Hypertrophy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00149344
Start Date
September 1 2005
End Date
July 1 2011
Last Update
July 28 2011
Active Locations (1)
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1
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6