Breast HypertrophyNCT00149344
Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty
A study testing Vertical scar versus inferior pedicle reduction mammoplasty in people with Breast Hypertrophy, run by McMaster University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Hypertrophy
- What is being tested?
- Vertical scar versus inferior pedicle reduction mammoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 254 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Being tested
- Vertical scar versus inferior pedicle reduction mammoplasty
- Keywords
- cost-utility analysis;, breast reduction;, vertical scar mammoplasty;, pedicle reduction mammoplasty
- Medical subject headings
- Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertical scar versus inferior pedicle reduction mammoplastyRadiation
Vertical Scar Reduction Mammoplasty Inferior Pedicle Reduction Mammoplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life (utilities and disease specific)
Measured: 1 Year
Secondary outcomes (1)
Health care resource utilization as well as out-of-pocket expenses by patients and caregivers.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast HypertrophyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Society of Plastic Surgeons
- Investigators
- Achilleas Thoma, MD MSc FRCSC, Principal investigator, McMaster University / St. Joseph's Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149344
- Sponsor's protocol ID
- 05-2447
- Status last verified
- Jul 2011
- First submitted
- 6 Sep 2005
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Thoma A, Kaur MN, Tsoi B, Ziolkowski N, Duku E, Goldsmith CH. Cost-effectiveness analysis parallel to a randomized controlled trial comparing vertical scar reduction and inverted T-shaped reduction mammaplasty. Plast Reconstr Surg. 2014 Dec;134(6):1093-1107. doi: 10.1097/PRS.0000000000000751.
PubMed 25255113
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty: A Randomized Controlled Trial and Cost-Utility Analysis
- ClinicalTrials.gov ID
- NCT00149344
- Acronym / sponsor ID
- 05-2447
- Conditions
- Breast Hypertrophy
- Keywords
- cost-utility analysis;, breast reduction;, vertical scar mammoplasty;, pedicle reduction mammoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Society of Plastic Surgeons
- Study start
- Sep 2005
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vertical scar versus inferior pedicle reduction mammoplastyVertical Scar Reduction Mammoplasty Inferior Pedicle Reduction Mammoplasty | Radiation | – |
Primary outcome
Health related quality of life (utilities and disease specific)
Time frame: 1 Year
1 secondary outcome
Health care resource utilization as well as out-of-pocket expenses by patients and caregivers.
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
- Derived from this study: PubMed 25255113Thoma A, Kaur MN, Tsoi B, Ziolkowski N, Duku E, Goldsmith CH. Cost-effectiveness analysis parallel to a randomized controlled trial comparing vertical scar reduction and inverted T-shaped reduction mammaplasty. Plast Reconstr Surg. 2014 Dec;134(6):1093-1107. doi: 10.1097/PRS.0000000000000751.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Achilleas Thoma, MD MSc FRCSC principal investigator
McMaster University / St. Joseph's Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertical scar versus inferior pedicle reduction mammoplasty in people with Breast Hypertrophy, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (utilities and disease specific) (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00149344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2011.