NCT07485309

Periareolar Excision vs Pull-Through in Gynecomastia

A Randomized Controlled Trial Comparing Periareolar Excision Versus Pull-Through Techniques in Simon Grade I-IIb Gynecomastia: A Phenotype-Dependent Outcome Analysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynecomastia

Interventions

Type	Name	Description
PROCEDURE	Periareolar 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.
PROCEDURE	Pull-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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: Egypt