Clinical trial NCT03669679: Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty
Official title: Superomedial Pedicle Versus Inferior Pedicle in Breast Reduction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Hypertrophy
Keywords: breast reduction
mammaplasty
breast-q
patient satisfaction
patient reported outcome measures
superomedial pedicle
inferior pedicle
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 19
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient satisfaction
timeFrame: 6 months
measure: Blood loss
timeFrame: 24 hours
measure: Acute Complications
timeFrame: 2 weeks
measure: cosmetic outcomes
timeFrame: 6 months
measure: Breast Measurements
timeFrame: 6 months
measure: Duration of the procedure
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.