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临床试验/NCT03669679
NCT03669679已完成不适用

Superomedial Pedicle Versus Inferior Pedicle in Breast Reduction Surgery

Assiut University0 个研究点目标入组 19 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
19
主要终点
cosmetic outcomes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
22 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Bilateral breast hypertrophy

排除标准

  • 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.

研究组 & 干预措施

Group A

Active Comparator

participants undergoing superomedial pedicle breast reduction "Hall-Findlay technique"

干预措施: Breast reduction (Procedure)

Group B

Active Comparator

participants undergoing inferior pedicle breast reduction "Robbins technique"

干预措施: Breast reduction (Procedure)

结局指标

主要结局

cosmetic outcomes

时间窗: 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

时间窗: 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

时间窗: 6 hours

estimation of the duration of the surgery from sterilization until application of the dressing

Patient satisfaction

时间窗: 6 months

evaluation of patient satisfaction pre/post-operatively using Arabic translated valid version of Breast-Q Reduction/Mastopexy Module (version 1)

Blood loss

时间窗: 24 hours

estimation of hemoglobin level deficit by evaluating hemoglobin level 24 hours post-operatively

Acute Complications

时间窗: 2 weeks

monitoring for the incidence of nipple \& areola congestion/ischemia, hematoma, seroma, infection, wound dehisence or skin flaps congestion/ischemia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed El-Sayed Sharaf Ahmed

Assistant Lecturer

Assiut University

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