Breast Hypertrophy Clinical Trial
Official title:
Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty: A Randomized Controlled Trial and Cost-Utility Analysis
Verified date | July 2011 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 254 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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.) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Healthcare | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Society of Plastic Surgeons |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health related quality of life (utilities and disease specific) | 1 Year | No | |
Secondary | Health care resource utilization as well as out-of-pocket expenses by patients and caregivers. | 1 Year | No |
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