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Completed

NCT Number: NCT03669679

Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty

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.

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Key information

Conditions

Breast Hypertrophy Behavior Gigantomastia Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

22 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breast reduction

Procedure

breast reduction surgery for breast hypertrophy using either superomedial or inferior pedicle technique

Primary outcomes

  1. 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)

  2. Blood loss

    Time frame: 24 hours

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

  3. 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

  4. 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

  5. Breast Measurements

    Time frame: 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

  6. Duration of the procedure

    Time frame: 6 hours

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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Superomedial Pedicle Versus Inferior Pedicle in Breast Reduction Surgery

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2018
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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