Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty

Not Applicable

Completed

• Conditions: Breast Hypertrophy
• Interventions: Procedure: Breast reduction

• Registration Number: NCT03669679
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study Start: 2016-04-01
• Primary Completion: 2018-03-30
• Study Completion: 2018-05-30
• Status Verified: 2018-09
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Last Update Submitted: 2018-09-12
• Study First Posted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Breast reduction	participants undergoing superomedial pedicle breast reduction "Hall-Findlay technique"
Group B	Breast reduction	participants undergoing inferior pedicle breast reduction "Robbins technique"

Primary Outcome Measures

Name	Time	Method
cosmetic outcomes	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
Breast Measurements	6 months	* 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
Duration of the procedure	6 hours	estimation of the duration of the surgery from sterilization until application of the dressing
Patient satisfaction	6 months	evaluation of patient satisfaction pre/post-operatively using Arabic translated valid version of Breast-Q Reduction/Mastopexy Module (version 1)
Blood loss	24 hours	estimation of hemoglobin level deficit by evaluating hemoglobin level 24 hours post-operatively
Acute Complications	2 weeks	monitoring for the incidence of nipple \& areola congestion/ischemia, hematoma, seroma, infection, wound dehisence or skin flaps congestion/ischemia