Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669679
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed El-Sayed Sharaf Ahmed, 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.

Condition or disease Intervention/treatment Phase
Breast Hypertrophy Procedure: Breast reduction Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Superomedial Pedicle Versus Inferior Pedicle in Breast Reduction Surgery
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
participants undergoing superomedial pedicle breast reduction "Hall-Findlay technique"
Procedure: Breast reduction
breast reduction surgery for breast hypertrophy using either superomedial or inferior pedicle technique

Active Comparator: Group B
participants undergoing inferior pedicle breast reduction "Robbins technique"
Procedure: Breast reduction
breast reduction surgery for breast hypertrophy using either superomedial or inferior pedicle technique




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Publications:
Layout table for additonal information
Responsible Party: Ahmed El-Sayed Sharaf Ahmed, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03669679    
Other Study ID Numbers: SM Vs Inf. Pedicle in BR
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed El-Sayed Sharaf Ahmed, Assiut University:
breast reduction
mammaplasty
breast-q
patient satisfaction
patient reported outcome measures
superomedial pedicle
inferior pedicle
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertrophy
Pathological Conditions, Anatomical