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Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty

Primary Purpose

Breast Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Breast reduction
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Hypertrophy focused on measuring breast reduction, mammaplasty, breast-q, patient satisfaction, patient reported outcome measures, superomedial pedicle, inferior pedicle

Eligibility Criteria

22 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group A

    Group B

    Arm Description

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

    participants undergoing inferior pedicle breast reduction "Robbins technique"

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 12, 2018
    Last Updated
    September 12, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03669679
    Brief Title
    Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty
    Official Title
    Superomedial Pedicle Versus Inferior Pedicle in Breast Reduction Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    March 30, 2018 (Actual)
    Study Completion Date
    May 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Hypertrophy
    Keywords
    breast reduction, mammaplasty, breast-q, patient satisfaction, patient reported outcome measures, superomedial pedicle, inferior pedicle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    participants undergoing superomedial pedicle breast reduction "Hall-Findlay technique"
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    participants undergoing inferior pedicle breast reduction "Robbins technique"
    Intervention Type
    Procedure
    Intervention Name(s)
    Breast reduction
    Intervention Description
    breast reduction surgery for breast hypertrophy using either superomedial or inferior pedicle technique
    Primary Outcome Measure Information:
    Title
    Patient satisfaction
    Description
    evaluation of patient satisfaction pre/post-operatively using Arabic translated valid version of Breast-Q Reduction/Mastopexy Module (version 1)
    Time Frame
    6 months
    Title
    Blood loss
    Description
    estimation of hemoglobin level deficit by evaluating hemoglobin level 24 hours post-operatively
    Time Frame
    24 hours
    Title
    Acute Complications
    Description
    monitoring for the incidence of nipple & areola congestion/ischemia, hematoma, seroma, infection, wound dehisence or skin flaps congestion/ischemia
    Time Frame
    2 weeks
    Title
    cosmetic outcomes
    Description
    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
    Time Frame
    6 months
    Title
    Breast Measurements
    Description
    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
    Time Frame
    6 months
    Title
    Duration of the procedure
    Description
    estimation of the duration of the surgery from sterilization until application of the dressing
    Time Frame
    6 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24867750
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10946926
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29124379
    Citation
    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.
    Results Reference
    background

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    Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty

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