Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty

NCT00149344 | Completed

• 1 other identifier: 05-2447
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Breast Hypertrophy

Keywords

cost-utility analysis;; breast reduction;; vertical scar mammoplasty;; pedicle reduction mammoplasty

Outcome Measures

Primary Outcomes (1)

• Health related quality of life (utilities and disease specific)

  1 Year

Secondary Outcomes (1)

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

  1 Year

Interventions

Vertical scar versus inferior pedicle reduction mammoplasty RADIATION

Vertical Scar Reduction Mammoplasty Inferior Pedicle Reduction Mammoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• McMaster University: lead
• Canadian Society of Plastic Surgeons: collaborator

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

• 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.

  PMID: 25255113 DERIVED

MeSH Terms

Conditions

Gigantomastia

Study Officials

• Achilleas Thoma, MD MSc FRCSC

  McMaster University / St. Joseph's Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: September 1, 2005
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 28, 2011

Record last verified: 2011-07

Locations

CA (1)