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
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
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
NCT ID
NCT03669679
First Posted
September 12, 2018
Last Updated
September 12, 2018
Sponsor
Assiut University
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
Learn more about this trial
Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty
We'll reach out to this number within 24 hrs