Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty

NCT ID: NCT03669679

Last Updated: 2018-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2018-05-30

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.

Conditions

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Breast Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

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

Group Type ACTIVE_COMPARATOR

Breast reduction

Intervention Type PROCEDURE

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

Group B

participants undergoing inferior pedicle breast reduction "Robbins technique"

Group Type ACTIVE_COMPARATOR

Breast reduction

Intervention Type PROCEDURE

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

Interventions

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Breast reduction

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

Intervention Type PROCEDURE

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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed El-Sayed Sharaf Ahmed

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 24867750 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10946926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29124379 (View on PubMed)

Other Identifiers

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SM Vs Inf. Pedicle in BR

Identifier Type: -

Identifier Source: org_study_id

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