Clinical trial NCT04063722: Modified Benelli Procedure For Subcutaneous Mastectomy
Official title: A Randomized Controlled Trial Modified Benelli Procedure For Subcutaneous Mastectomy In Gynecomastia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecomastia
Surgical Incision
Lead sponsor: Al-Kindy College of Medicine
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 150
Sex: MALE
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* all patients with gynecomastia

Exclusion Criteria:

* Patients with Grade I gynecomastia because of no skin excess
* patients with grade IV due to the need of more extensive procedures

Primary outcomes:
measure: prevalence of proper postoperative nipple-areolar complex position: the distance from the midclavicular point to the postoperative nipple areola complex position.
timeFrame: Documented on one occasion, at 6 months postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Al kindy college of medicine university of Baghdad
name: Riyadh M Hasan, C.A.B.S.
role: STUDY_CHAIR
References: