- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03669679
Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty
Superomedial Pedicle Versus Inferior Pedicle in Breast Reduction Surgery
Study Overview
Detailed Description
The female breast is one of the most attractive aesthetic areas in female anatomy. The size, shape, and symmetry of the breasts can have a dramatic effect on the women's wellbeing. Reduction mammaplasty is certainly one of the operations; plastic surgeons can significantly contribute to a woman's quality of life.
Macromastia or Breast Hypertrophy is a pathologic condition consisting of hypertrophy of the breast. It generates both physical and psychological distress, presenting a significant threat to a woman's health-related quality of life. Regarding Physical Distress Macromastia always associated with a number of musculoskeletal complications, including neck pain, back pain, headache, peripheral neuralgias, and shoulder pain. Often, women with mammary hypertrophy experience intertriginous skin maceration and other rashes, as well as infections all the result of heavy, pendulous breasts. In short, a woman's breast size can affect her attitudes, career choices, and personal life in many ways.
Ideal technique should end in a beautiful breast, which has good size with fullness in the upper part, attractive shape with adequate projection, elegant curves, and a nipple areola complex that is pleasing in shape and position. The result should last over years.
The inferior pedicle technique has been described with many variations by surgeons such as Ribeiro and Robbins with the nipple and areola being carried on a dermal pedicle, and it is probably one of the most popular breast reduction techniques currently in use in the United States. Advantages of this are well known. It is a rapid and safe technique that can be used on almost every breast size. It has been shown to be as good as or better than other techniques in the preservation of the neurovascular supply to the nipple. It is easily taught and learned.
The superomedial pedicle technique was first described by Orlando & Gutherie as a modification of the superior pedicle technique. In this technique the nipple & areola (NAC) is transposed on a superomedial de-epithelialized pedicle which contains a thin layer of subcutaneous tissue to protect the dermal blood supply.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Bilateral breast hypertrophy
Exclusion Criteria:
- Congenital breast anomalies.
- Pregnant, lactating or smoker patient.
- Previous breast reductions.
- Co-morbid diseases e.g. diabetes , liver cirrhosis or thyroid disorders.
- Body dysmorphic disorder
- Patients on long term medications e.g. immunosuppressive drugs, steroids or cytotoxic drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A
participants undergoing superomedial pedicle breast reduction "Hall-Findlay technique"
|
breast reduction surgery for breast hypertrophy using either superomedial or inferior pedicle technique
|
Active Comparator: Group B
participants undergoing inferior pedicle breast reduction "Robbins technique"
|
breast reduction surgery for breast hypertrophy using either superomedial or inferior pedicle technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: 6 months
|
evaluation of patient satisfaction pre/post-operatively using Arabic translated valid version of Breast-Q Reduction/Mastopexy Module (version 1)
|
6 months
|
Blood loss
Time Frame: 24 hours
|
estimation of hemoglobin level deficit by evaluating hemoglobin level 24 hours post-operatively
|
24 hours
|
Acute Complications
Time Frame: 2 weeks
|
monitoring for the incidence of nipple & areola congestion/ischemia, hematoma, seroma, infection, wound dehisence or skin flaps congestion/ischemia
|
2 weeks
|
cosmetic outcomes
Time Frame: 6 months
|
evaluation of breast symmetry, contour, projection, postoperative scars and shape of nipple & areola using standard photographs (anteroposterior, lateral and oblique views) by twoplastic surgery experts
|
6 months
|
Breast Measurements
Time Frame: 6 months
|
|
6 months
|
Duration of the procedure
Time Frame: 6 hours
|
estimation of the duration of the surgery from sterilization until application of the dressing
|
6 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Antony AK. Reply: A matched cohort study of superomedial pedicle vertical scar breast reduction (100 breasts) and traditional inferior pedicle wise-pattern reduction (100 breasts): an outcomes study over 3 years. Plast Reconstr Surg. 2014 Jun;133(6):885e-887e. doi: 10.1097/PRS.0000000000000210. No abstract available.
- Ramon Y, Sharony Z, Moscona RA, Ullmann Y, Peled IJ. Evaluation and comparison of aesthetic results and patient satisfaction with bilateral breast reduction using the inferior pedicle and McKissock's vertical bipedicle dermal flap techniques. Plast Reconstr Surg. 2000 Aug;106(2):289-95; discussion 295-7. doi: 10.1097/00006534-200008000-00006.
- Cabral IV, da Silva Garcia E, Sobrinho RN, Pinto NLL, Juliano Y, Veiga-Filho J, Ferreira LM, Veiga DF. Use of the BREAST-Q Survey in the Prospective Evaluation of Reduction Mammaplasty Outcomes. Aesthetic Plast Surg. 2018 Apr;42(2):388-395. doi: 10.1007/s00266-017-1009-6. Epub 2017 Nov 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SM Vs Inf. Pedicle in BR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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