Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04063722 |
| Other study ID # |
7 Al-KindyCM |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2010 |
| Est. completion date |
July 1, 2016 |
Study information
| Verified date |
August 2019 |
| Source |
Al-Kindy College of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study included 150 patients with gynecomastia (Grade II and III) for the period between
January 2010 and January 2016 who attended private hospitals and Al- Kindy Teaching Hospital.
The patients were divided into two groups according to the operative techniques used. Group A
included 75 patients treated surgically with subcutaneous mastectomy using periareolar
incision. Group B; included the other 75 patients who were managed by "modified Benelli
technique". The subcutaneous mastectomy using "modified Benelli technique" showed a
significantly lower operating time due to ample access for excision of breast tissue.
Excision of excess skin allowed the areola to retain a cosmetically more acceptable position.
There was a lot of pleating of the skin compared to the other technique using the periareolar
incision.
Description:
Patients with true gynecomastia, attending Al-Kindy Teaching Hospital and private hospitals,
Baghdad, Iraq, from January 2010 to January 2016 were enrolled in the study. Grading of
gynecomastia was done according to Cordova and Moschella classification (6). Patients with
Grade I were excluded because of no skin excess, while grade IV were excluded due to the need
of more extensive procedures. The study protocol was reviewed and approved by the Scientific
and Ethical Committee of Al-Kindy College of medicine and Al-kindy Teaching hospital in the
committee number 6 in 20-5-2019 (Ethical approval number and Date). Written informed consents
were obtained from all patients as an action on acceptance. All enrolled patients were
operated by the same surgeon. Patients were randomly assigned to one of the following
surgical technique: Group A; included patients who underwent subcutaneous mastectomy using
periareolar incision with lateral and medial extension as needed according to Webster(12).
Group B; included patients who were treated by the proposed Modified Benelli Technique (MBT)
using the following operative procedure:
First ask the patient to stand up and draw the a line referring to the midline of the chest
then mark the ideal breast meridian at 18 cm from midclavicular point to show the position
where the nipple should be placed (point X) with skin marker pen and assess the quantity of
surplus skin to be excised. After that, ask the patient to lie down on the couch and a
periareolar line was marked ( line A) above and medial to the areola and a second radial line
above it and parallel to it passing in the point (X) was made and named line B. The ends of
this line is curved to approximate and connect to both ends of the line A . Then, the patient
is given general anesthesia and the two incisions were made on the lines A and B i.e.
periareolar incision above and medial to the areola with a second incision above it and
connecting both ends . Next, the whole thickness of the excess skin between line A and the
line B was excised (Simon classification 2A, 2B and 3) and subcutaneous mastectomy was done
and sent to histopathology. Later on, bleeding control was done by good hemostasis and
suction drain was put in its proper site. Finally subcuticular suturing was done by
approximation of two incisions using Nylon 3/0. Lastly, sterile pressure dressing was placed.
The result of both groups were compared in terms of operating time, nipple-areola complex
location, post-operative complications including, pleating of the skin at suture line,
hematoma, bruising at the site of incision, , soft tissue deformity, seroma, hypoesthesia of
nipple-areola complex, wound dehiscence, areolar epidermolysis, and hypertrophic scarring.
