Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty

Breast Hypertrophy Clinical Trial

Official title:

Superomedial Pedicle Versus Inferior Pedicle in Breast Reduction Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669679
• Other study ID #: SM Vs Inf. Pedicle in BR
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: May 30, 2018

Study information

• Verified date: September 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Hypertrophy
• Hypertrophy

Intervention

Procedure:
• Breast reduction
breast reduction surgery for breast hypertrophy using either superomedial or inferior pedicle technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	evaluation of patient satisfaction pre/post-operatively using Arabic translated valid version of Breast-Q Reduction/Mastopexy Module (version 1)	6 months
Primary	Blood loss	estimation of hemoglobin level deficit by evaluating hemoglobin level 24 hours post-operatively	24 hours
Primary	Acute Complications	monitoring for the incidence of nipple & areola congestion/ischemia, hematoma, seroma, infection, wound dehisence or skin flaps congestion/ischemia	2 weeks
Primary	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	6 months
Primary	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	6 months
Primary	Duration of the procedure	estimation of the duration of the surgery from sterilization until application of the dressing	6 hours