A Randomized Controlled Trial Comparing Periareolar Excision Versus Pull-Through Techniques in Simon Grade I-IIb Gynecomastia: A Phenotype-Dependent Outcome Analysis
Phase: NA
Conditions: Gynecomastia
Sponsor: Kafrelsheikh University

 
 
 
Prospective Analysis and Comparison of Periareolar 
Excision (Delivery) Technique and Pull-Through 
Technique for the Treatment of Gynecomastia 
 
Protocol of Thesis 
Submitted for partial fulfillment of Master Degree in General Surgery 
By 
Asem Hamada Nasr Elkot 
M.B.B.CH Resident of Plastic Surgery,  
Faculty of Medicine, Kafrelsheikh University 
 
Under Supervision Of 
 
Prof.Dr. Khalid Ahmed Ismail 
Professor of General Surgery 
Faculty of Medicine - KafrElsheikh University 
 
ProF.DR. NAHLA NOSIER 
 
Professor of clinical pathology 
Faculty of Medicine - KafrElsheikh University 
 
Dr. Safwat Adel Mohamed Hegazy 
Lecturer of Plastic Surgery 
Faculty of medicine - KafrElsheikh University 
 
 
2024 
 
 
 
Kafrelsheikh University 
Faculty of Medicine 
General surgery department 

Introduction 
 
Gynecomastia is described as the excessive breast enlargement in males, 
mimicking that of females. The term is derived from two Greek words, ctme ( 
(female) and larso1 (breast). The incidence as reported in the literature 
ranges from 32 to 36% among adult males, sometimes even as high as 60% in 
adolescent boys. Gynecomastia results from an absolute or relative 
imbalance between estrogens (which stimulate the development of breast 
tissue) and androgens. Estrogen stimulates breast development, whereas 
androgens act as an antagonist. Early in the development of gynecomastia, 
ductal epithelium proliferates and stromal and connective tissue hyperplasia 
and edema occur. Gynecomastia is classified into physiological, pathological, 
pharmacological and idiopathic according to the etiology, with the most 
common being idiopathic. Three histological patterns have been described 
according to the different degrees of stromal and ductal proliferation: the 
florid pattern, the fibrous pattern and the intermediate one. The three types 
represent the stages of evolution of the pathology. After one year, 
hypertrophic breast tissue becomes irreversibly fibrotic. Thus, medical 
treatment usually has limited success.  
Depending on morphology and volume, Simon in the year 1973 classified it 
into four different groups. a) I—Minor breast enlargement without skin 
redundancy b) IIa—Moderate breast enlargement without skin redundancy c) 
IIb—Moderate breast enlargement with minor skin redundancy d) III—Gross 
breast enlargement with skin redundancy mimicking female breast ptosis. 
Simon’s classification provides a simple guideline for diagnosis and 
management. The different amounts of adipose tissue, parenchyma and skin 
redundancy are paramount in selecting patients and planning surgical 
strategies. Various treatment modalities have been described that 
accomplish the removal of involved tissue by direct open excision, liposuction 
or some combination. Direct excision of the male breast may result in 
irregular contour defects and unsightly scarring that can be esthetically 
worse than the presenting problem.  

Liposuction easily removes adipose tissue but is less effective in treating the 
fibrous parenchymal component of the breast. Combining traditional 
liposuction with direct pull-through surgical excision of the breast bud has 
been described by Morselli. Some modify his technique to incorporate 
ultrasonic liposuction, which more effectively treats fibrous fatty tissues. This 
method permits both liposuction and sharp resection of breast parenchyma 
through a single 1-cm incision placed strategically along the inferior margin of 
the areola or in the inframammary fold. Liposuction in gynecomastia is 
performed using two small incisions on either side of the chest and gland 
excision through a periareolar incision. A drain was introduced via the 
liposuction port or through a separate incision. Liposuction is comparatively 
rapid, less invasive, and essentially non-scarring and has fewer risks. Many 
studies have documented the results and outcome of standard liposuction 
through a periareolar incision in gynecomastia. The present study was thus 
planned to compare cases of gynecomastia treated by standard liposuction 
with the periareolar excision (delivery) technique versus liposuction with the 
pull-through technique. We designed this study to evaluate the operative 
results with both the techniques and compared the functional and esthetic 
outcomes among both the techniques. Anthropometric analysis and patient 
satisfaction were assessed and compared. 
 
Aim of the work 
The aim of the current study was to  
 Primary to compare the effectiveness of the Periareolar Excision 
(Delivery) Technique versus the Pull-Through Technique in treating 
gynecomastia. 
 Secondary to evaluate postoperative complications, aesthetic 
outcomes, and patient satisfaction between the two techniques. 
 
 

Patients and Methods 
 
Study design and setting: 
This study will utilize a prospective cohort design.  Randomized 
controlled trial (RCT). 
Population:  
The study group consisted of consecutive patients diagnosed of gynecomastia 
of duration greater than 12 months. All procedures were performed in the same 
hospital and by the same surgical team. 
Duration 
The study will be conducted over a period of 12 months, including follow-up. 
 
Inclusion Criteria: 
• Male patients aged 18-50 years. 
• Clinical diagnosis of gynecomastia confirmed by physical examination 
and ultrasonic studies. 
• No prior surgical intervention for gynecomastia. 
• Ability to provide informed consent. 
 
Exclusion Criteria: 
• Patients with contraindications for surgery. 
• Patients with a history of breast cancer or other malignancies. 
• Significant comorbidities that may interfere with recovery. 
 

Consent: 
An informed consent will be taken from all the patients subjected to the 
study. 
 
Preoperative methodology: 
All patients will be subjected to the following preoperative assessment 
including;  
▪ Full history  
- Personal history including age, occupation and habits like 
smoking and alcoholism. 
- Present history including symptoms i.e. onset and duration of 
enlargement, breast symptoms (pain, tenderness, discharge). 
- Past history including : 
o Medical co-morbidities as diseases (i.e. DM, malignancy). 
o Drugs i.e. antipsychotics, spironolactone, verapamil, and 
cimetidine ,steroid or immunosuppression drugs, or 
recreational drug use  
o Surgical history (i.e. previous cardiothoracic surgery, chest 
trauma) 
- Social/psychological effects of breast enlargement. 
- Family history and reproductive history should also be 
obtained 
 
▪ General examination:   
Signs/symptoms of liver disease, malnutrition, kidney failure, 
hyper- or hypothyroidism, weight changes, adrenal disease, and 
malignancy (i.e. thyromegaly, exophthalmos, hepato- or 
splenomegaly, abdominal masses, ascites or cirrhotic stigmata) 
▪ Local examination:  
Breasts should be assessed for 

Symmetry, bilateralism, nipple position and abnormalities, 
glandular or fat predominance, skin excess, degree of ptosis, and 
nodules or masses. 
Axillary and supraclavicular lymph node basins should be 
examined in the setting of a suspicious mass. 
 
▪ Standardized color digital photography of the cases 
 
▪ Investigations 
- Routine preoperative investigations: CBC, coagulation profile, 
liver function tests, kidney function tests 
- Ultrasonography assessment of breast. 
- ECHO if the patient has cardiogenic disease history. 
- Biopsy is indicated if findings on physical examination are 
consistent with a breast neoplasm.   
- Laboratory testing should be directed by abnormalities 
identified on history and physical exam i.e. thyroid profile test 
in hyperthyroidism. 
 
Operative methodology: 
Prophylactic antibiotics covering skin flora are administered 2 hours prior to 
skin incision 
• Preoperative Planning  
- Preoperative markings are performed with the patients in the upright 
sitting or standing position.  
- Breast tissue is marked with its boundaries and topographic heights by 
circular shape pattern 
- The inframammary fold, sternal midline and two small incisions on both 
sides of the chest for liposuction cannula introduction were marked. 
These were marked on the anterior axillary line as follows: one at the 
level of the inframammary fold and a second one at the superior border 
of breast. 

• Positioning 
Surgery is performed under general anesthesia as an outpatient 
procedure. Patients are positioned supine with arms abducted and secured 
to padded, adjustable arm boards. The hips are centered over the bed 
break, and the patient is secured with a safety strap.  
- Intraoperative assessment of adequate/symmetric resection requires sitting 
the patients fully upright in the operating room and they should be secured 
in a manner that enables this to be safely accomplished.  
- Sequential compression devices or elastic stocking are applied to the lower 
extremities.  
- The entire anterior chest is prepped into the field to allow intraoperative 
symmetry assessment.   
 
 
 
• Operative technique  
The breast was infiltrated with tumescent fluid (1 L Ringer lactate with 20 
ml of 2% lignocaine, 1 ml of 1:1000 adrenaline). A 3-mm-diameter 
liposuction cannula with a Mercedes Benz tip was inserted through the 
inframammary incision, and liposuction of the ipsilateral breast was done. It 
was followed by the liposuction from the superior incision done in a 
crisscross manner with the aim to break the inframammary fold. The similar 
procedure was performed on the opposite breast as well. A power-assisted 
device was used for the liposuction. At the end of this step of liposuction, 
the sub-areolar part of both the breasts remains unaddressed. The liposuction 
was done, and a 5-mm-thick layer of fat was left underneath the skin at all 
the regions. The aspirated fat volume from each side was measured. 
 
Group A “Liposuction with Periareolar Excision (Delivery) Technique” 
A periareolar incision was given from the three to nine o’clock position in a 
semicircular manner, and this was followed by excision of glandular 
elements. A small sliver of gland is preserved underneath the nipple–areola 
complex to preserve the vascularity. The periareolar incision was closed in 

two layers. The inner subcutaneous layer was closed with intermittent 
delayed absorbable suture, and the skin was closed with subcuticular 
absorbable suture. The liposuction stab incisions were kept open to allow 
drainage of fluids. It was followed by sterile padded dressing, and a pressure 
garment was applied immediately. Drains were not used. 
 
Group B “Liposuction with Pull-through Technique” 
Parenchymal excision was difficult to estimate on physical examination. To 
surgically excise the gland, we introduced a long Kocher forceps through the 
inferior incision made for liposuction. By grasping the lateral aspect of the 
gland, we pulled it toward the incision site and excised it. This maneuver is 
repeated in different directions. To excise the established amount of 
parenchyma and to shape the remaining gland, we palpated the breast after 
each gland removal. We left a small amount of gland behind the areola to 
avoid the depression underneath the nipple–areola complex. The liposuction 
stab incisions sites were not closed, to allow drainage of any fluid. Sterile 
padded dressing was applied followed by immediate application of a 
pressure garment. 
 
 
• Post-operative methodology:  
 
These cases are performed as ambulatory procedures with patients going home 
the same day.  
The dressing was changed after 24 h. 
Patients are instructed to wear a chest compression garment or Ace wrap for 2 
to 4 weeks postoperatively. This maintains pressure on the chest to minimize 
hematoma and seroma formation.  
Postoperative follow-up visits are scheduled at 1 week, 4 weeks, and 4 to 6 
months.  
 
 

Follow-Up 
Every patient will be assessed of symmetry and nipple areola complex and 
clinical assessment of both breast tissue and complications i.e. hematoma, 
seroma, infection and undesired scar. 
 
Photography at the regular follow-up visits. The photography will be under 
uniform lighting at a fixed distance (one arm span of the observer) with the 
same standard background. 
 The following profiles will include for each patient: frontal, oblique and side 
view (right and left). The person will be placed in the frame in the same 
position, with arms by their sides, or in the same position, for both before and 
after surgery. 
  
Outcome Measures 
- Primary Outcome: 
Reduction in Gynecomastia is measured by pre- and post-operative 
photographs and clinical assessments. 
- Secondary Outcomes: 
▪ Complications: Rates of infection, hematoma, seroma, and other 
adverse effects. 
▪ Aesthetic Results: Assessed by standardized photographic evaluation 
and patient satisfaction surveys. 
▪ Recovery Time: Time to return to normal activities and any post-
operative discomfort. 
 
Data Collection 
- Preoperative Data: Patient demographics, baseline gynecomastia 
severity. 
- Intraoperative Data: Details of the surgical procedure and any 
complications. 
- Postoperative Data: Complications, recovery timeline, aesthetic 
outcomes, and patient satisfaction. 
Photography will be collected at the course of the study 

Anthropometric analysis and patient satisfaction were assessed and compared. 
Electronic case report forms will be used to ensure accurate and consistent 
data entry. 
Sample Size Calculation 
Sample size was calculated using G*Power (v3.1) to detect a moderate 
effect (Cohen’s d = 0.65) in total BODY-Q satisfaction (80% power, α 
= 0.05), requiring 31 patients per group. Sixty-four patients were 
randomized 1:1 to: 
• Group A: Periareolar Excision (n= 32) 
• Group B: Pull-Through Technique (n= 32) 
 
Randomization and Blinding 
Randomization was performed using computer-generated random list, 
and sealed opaque envelopes were used to hide allocation. 
Statistical Analysis 
Data were analyzed using SPSS v26. Normality was assessed with Shapiro–
Wilk testing. Parametric data were compared using independent t-test (Welch 
correction as needed); nonparametric data with Mann–Whitney U test; 
categorical variables with Chi-square or Fisher’s exact test. 
Effect sizes were reported as Cohen’s d, r (Z/√N), and partial η². Two-way 
ANOVA assessed Technique × Simon Grade interaction. A two-tailed p < 
0.05 was considered statistically significant. 
 
Ethical Considerations 
The study will be conducted in accordance with the Declaration of 
Helsinki and approved by the Institutional Review Boards (I.R.B.) of 
Kafrelsheikh University Hospital, and a written informed consent will be 
obtained from all participants before enrollment in the study. 
 

 
Results 
Using appropriate statistical methods, all collected data will be 
presented in tables, suitable graphs, and analyzed by computer software 
according to methods. 
 
Discussion 
The discussion will be done later, depending on the results. 
 
Conclusion and recommendations 
Will be derived from the findings of the study

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