Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty

Study Overview
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Brief Summary
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The aim of this study is to evaluate Superomedial pedicle and Inferior pedicle techniques in breast reduction for Egyptian females and compare between both pedicles regarding cosmetic outcomes, possible complications, patient satisfaction and time of operation.

Detailed Description
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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.

Official Title
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Superomedial Pedicle Versus Inferior Pedicle in Breast Reduction Surgery

Conditions
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Breast Hypertrophy

Intervention / Treatment
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* Procedure: Breast reduction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>participants undergoing superomedial pedicle breast reduction Hall-Findlay technique | Procedure: Breast reduction<br>* breast reduction surgery for breast hypertrophy using either superomedial or inferior pedicle technique<br>|
| Active Comparator: Group B<br>participants undergoing inferior pedicle breast reduction Robbins technique | Procedure: Breast reduction<br>* breast reduction surgery for breast hypertrophy using either superomedial or inferior pedicle technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | evaluation of patient satisfaction pre/post-operatively using Arabic translated valid version of Breast-Q Reduction/Mastopexy Module (version 1) | 6 months | 
| Blood loss | estimation of hemoglobin level deficit by evaluating hemoglobin level 24 hours post-operatively | 24 hours | 
| Acute Complications | monitoring for the incidence of nipple & areola congestion/ischemia, hematoma, seroma, infection, wound dehisence or skin flaps congestion/ischemia | 2 weeks | 
| cosmetic outcomes | 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 | evaluation of breast vertical meridian and nipple to infra-mammary fold pre/post-operatively distance using tape measure evaluation of breast degree of ptosis using Regnault's classification | 6 months | 
| Duration of the procedure | estimation of the duration of the surgery from sterilization until application of the dressing | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast reduction, mammaplasty, breast-q, patient satisfaction, patient reported outcome measures, superomedial pedicle, inferior pedicle