Gynecomastia
Conditions
Keywords
Gynecomastia Surgery, Periareolar Excision, Pull-through Technique, Simon Classification, BODY-Q, Chest Contouring
Brief summary
This prospective randomized controlled trial compares periareolar excision and pull-through techniques in 64 patients with Simon Grade I-IIb gynecomastia. Patients were randomized 1:1 and followed for 6 months. The primary outcome was total patient satisfaction measured using the Rasch-transformed BODY-Q Chest Module. Secondary outcomes included anthropometric measurements, recovery parameters, complication rates, and blinded aesthetic evaluation. A formal interaction analysis assessed whether surgical superiority differed according to disease severity.
Detailed description
Gynecomastia is a benign proliferation of fibroglandular tissue in the male breast that alters chest contour and may significantly affect body image, confidence, and psychosocial well-being. Although many cases resolve spontaneously during adolescence, a proportion persist and require surgical correction. Multiple surgical techniques have been described, including traditional periareolar excision and minimally invasive approaches such as the pull-through technique combined with liposuction. However, consensus remains limited regarding the optimal surgical technique, particularly across different grades of gynecomastia severity. This prospective randomized controlled trial was conducted at the Plastic Surgery Department, Faculty of Medicine, Kafr El-Sheikh University, Egypt, to compare outcomes between periareolar excision and the pull-through technique in patients with Simon Grade I-IIb gynecomastia. The study aimed to determine whether surgical effectiveness differs according to disease severity and tissue phenotype. Sixty-four male patients aged 18-50 years with persistent gynecomastia were randomized in a 1:1 ratio to undergo either periareolar glandular excision or the pull-through technique following liposuction. Randomization was performed using a computer-generated sequence with allocation concealment through sealed opaque envelopes. All procedures were performed under general anesthesia on an outpatient basis. The primary outcome was patient satisfaction measured at 6 months postoperatively using the Rasch-transformed BODY-Q Chest Module. Secondary outcomes included domain-level BODY-Q scores, objective anthropometric measurements, postoperative complications, recovery parameters (including time to return to work and hospital stay), glandular specimen weight, and blinded aesthetic evaluation based on standardized postoperative photographs assessed by independent plastic surgeons. Statistical analysis included comparisons between groups and interaction analysis to determine whether treatment effects varied according to Simon grade. The study was designed to provide evidence supporting phenotype-based surgical decision-making in gynecomastia management. This trial was retrospectively registered at ClinicalTrials.gov. The study was initiated prior to institutional establishment of a formal clinical trial registration pathway, and retrospective registration was completed to ensure transparency and compliance with international reporting standards.
Interventions
PROCEDUREPeriareolar Excision
Surgical correction of gynecomastia using a semicircular inferior periareolar incision to allow direct glandular excision following liposuction. A thin subareolar tissue layer is preserved to prevent nipple depression and maintain contour.
PROCEDUREPull-Through Technique
Minimally invasive surgical correction of gynecomastia using liposuction followed by glandular extraction through the liposuction incision using the pull-through technique with controlled traction and segmental excision.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants were blinded to the surgical technique performed. Postoperative aesthetic outcomes were evaluated using standardized photographs assessed by independent board-certified plastic surgeons who were blinded to treatment allocation.
Intervention model description
Participants with Simon Grade I-IIb gynecomastia were randomized in a 1:1 ratio to undergo either periareolar excision or pull-through technique. Outcomes were compared between parallel groups over a 6-month follow-up period.
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Male patients aged 18 to 50 years * Clinically diagnosed Simon Grade I-IIb gynecomastia * Persistent gynecomastia for more than 18 months * Candidates for surgical correction under general anesthesia * Provided written informed consent to participate in the study
Exclusion criteria
* Simon Grade III gynecomastia requiring skin excision * Gynecomastia secondary to untreated endocrine disorders * Chronic hepatic or renal disease * Suspected or confirmed breast malignancy * Previous gynecomastia surgery * Active infection * Coagulopathy or bleeding disorders * Contraindications to general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Patient Satisfaction (BODY-Q Chest Module) | 6 months postoperative | Patient-reported satisfaction with chest appearance measured using the Rasch-transformed BODY-Q Chest Module questionnaire. Higher scores indicate greater satisfaction following gynecomastia surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Domain-level BODY-Q Scores | 6 months postoperative | Assessment of specific BODY-Q domains including chest appearance, nipple aesthetics, and scar perception after gynecomastia surgery. |
| Change in Chest Anthropometric Measurements | Preoperative and 6 months postoperative | Change from baseline in chest anthropometric parameters including chest circumference, nipple-to-suprasternal notch distance, nipple-to-acromion distance, nipple-to-midclavicular distance, and breast projection, measured in centimeters (cm). |
| Number of Participants With Postoperative Complications | Within 6 months postoperative | Number of participants experiencing postoperative complications including hematoma, seroma, infection, or need for revision surgery. |
| Length of Postoperative Hospital Stay | Within 30 days postoperative | Duration of hospital stay following gynecomastia surgery, measured in days. |
| Postoperative Pain Score | Postoperative day 1 | Postoperative pain assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain. |
| Time to Return to Work | Up to 6 months postoperative | Time from surgery to return to normal work or daily activities, measured in days. |
| Blinded Surgeon Aesthetic Evaluation Score | 6 months postoperative | Independent aesthetic evaluation of postoperative chest contour using standardized postoperative photographs assessed by board-certified plastic surgeons blinded to treatment allocation. Aesthetic outcome will be rated using a 5-point Likert scale, where 1 indicates a very poor aesthetic outcome and 5 indicates excellent aesthetic outcome. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORasem Elkot, MD
Plastic Surgery Department, Faculty of Medicine, Kafr El-Sheikh University
Outcome results
None listed