NCT07314086

A Clinical Effectiveness Study of Total Laparoscopic Subcutaneous Gland Resection Combined With Nipple-Areola Complex Lift in the Management of Moderate to Severe Gynecomastia in Males

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: First Affiliated Hospital of Harbin Medical University · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate and compare the treatment outcomes of total laparoscopic subcutaneous gland resection combined with nipple-areola complex (NAC) lift surgery against those of isolated laparoscopic surgery in the management of moderate to severe gynecomastia (GYN) in males.

Detailed description

Gynecomastia (GYN), characterized by unilateral or bilateral breast enlargement, has an incidence ranging from approximately 32.0% to 64.6%, with a progressively increasing trend observed in recent years . Clinically, GYN is categorized into primary and secondary forms: the former is associated with physiological fluctuations in hormonal levels, whereas the latter is primarily attributable to underlying metabolic or neoplastic conditions, as well as medication use. Surgical intervention remains the mainstay of treatment for persistent or symptomatic cases. Given that the male breast is a solid, non-cavitary organ, conventional open surgical approaches have traditionally employed periareolar, crescentic, or double-ring incisions to excise subcutaneous glandular tissue . These techniques, however, are often associated with conspicuous scarring, suboptimal cosmetic results, and relatively high rates of postoperative complications. The advent of liposuction and tumescent lipolysis techniques in the 1990s overcame the technical challenge of cavity creation, thereby facilitating the development of endoscopic approaches. Over the past decade, significant advancements have been achieved through the integration of lipolysis and non-lipolysis techniques, concealed incision sites (e.g., axillary or lateral thoracic approaches), multi-port and single-port endoscopic systems, and robotic-assisted surgery using the Da Vinci Si platform . As a result, the therapeutic objective has evolved from mere glandular excision toward achieving optimal aesthetic outcomes with minimal visible scarring. The 2021 Expert Consensus and Operational Guidelines for Endoscopic Surgery in Breast Diseases established the 5S principles for GYN surgery: (1) complete removal of glandular tissue (sweep); (2) placement of inconspicuous, hidden incisions (scarless); (3) bilateral symmetry; (4) restoration of normal male chest contour (shape); and (5) smooth postoperative skin surface (smoothing) . Nevertheless, in patients with moderate to severe GYN, redundant skin following endoscopic resection frequently leads to malposition of the nipple-areola complex (NAC), including ptosis, depression, or wrinkling, which compromises skin smoothness and undermines both the 5S goals and overall aesthetic satisfaction. To address this limitation, our research team has developed an innovative technique termed the "Nipple-Areola Complex (NAC) Aesthetic Wrinkle-Reducing Band Lifting and Fixation Technique." This minimally invasive approach effectively manages postoperative skin redundancy without additional incisions, enabling precise repositioning of the NAC and improving skin contour. Statistical analysis demonstrates that this technique contributes significantly to enhancing aesthetic outcomes and patient satisfaction in the management of moderate to severe GYN.

Conditions

• Gynecomastia

Timeline

• Start date: 2021-09-01
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: China