Comparison of Endoscopic and Open Surgery for Gynecomastia

Prospective Comparative Evaluation of Different Surgical Techniques in the Treatment of Gynecomastia: A Multicenter Study

The goal of this observational study is to compare the clinical outcomes, safety, and patient satisfaction of endoscopic versus conventional open surgical techniques in adult male patients undergoing surgery for gynecomastia.

The main questions it aims to answer are:

• Does endoscopic gynecomastia surgery provide better aesthetic outcomes and patient satisfaction compared with conventional open surgery?
• Does endoscopic surgery reduce postoperative complications, sensory changes of the nipple-areola complex, and visible scarring compared with conventional open surgery?

Researchers will compare patients undergoing endoscopic nipple-areola complex-preserving mastectomy with patients undergoing conventional open nipple-areola complex-preserving mastectomy to evaluate differences in surgical outcomes, complications, cosmetic results, and quality of life.

Participants will:

• Undergo gynecomastia surgery as part of their routine clinical care using either an endoscopic or conventional open technique.
• Attend routine postoperative follow-up visits for up to 12 months.
• Complete patient-reported outcome assessments, including pain and satisfaction questionnaires.
• Undergo evaluation of scar quality, nipple-areola complex sensation, and postoperative complications during follow-up.

Study Overview

• Status: Recruiting
• Conditions: Gynecomastia
• Intervention / Treatment: Procedure: Endoscopic Nipple-Areola Complex-Preserving Mastectomy; Procedure: Conventional Open Nipple-Areola Complex-Preserving Mastectomy

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: MEHMET OLCUM; Phone Number: +905388101828; Email: mehmetolcum@hotmail.com
• Study Contact Backup: Name: MERVE TOKOCİN; Phone Number: +905356235594; Email: mervetokocin@gmail.com

Study Locations

• Turkey (Türkiye)
  • Antalya, Turkey (Türkiye)
    • Recruiting
    • Antalya City Hospital
    • Contact: Mehmet Olcum, MD; Phone Number: +905388101828; Email: mehmetolcum@hotmail.com
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Bagcilar Training and Research Hospital
    • Contact: Merve Tokocin, MD; Phone Number: +905356235594; Email: mervetokocin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult male patients with primary gynecomastia (Simon Grade II-III) who undergo surgical treatment at Antalya City Hospital and Istanbul Bagcilar Training and Research Hospital. Participants will undergo either endoscopic or conventional open nipple-areola complex-preserving mastectomy as part of routine clinical care and will be followed for 12 months to evaluate clinical outcomes, complications, aesthetic results, sensory outcomes, patient satisfaction, and quality of life.

Description

Inclusion Criteria:

• Male patients aged 18 to 60 years.
• Clinically and/or ultrasonographically confirmed primary gynecomastia with palpable glandular tissue ≥2 cm.
• Simon Grade II or Grade III gynecomastia.
• Patients requesting surgical treatment because of cosmetic and/or psychosocial concerns.
• Eligible for either endoscopic or conventional open nipple-areola complex-preserving mastectomy according to routine clinical practice.
• Ability to provide written informed consent.
• Willingness and ability to comply with the 12-month follow-up schedule.

Exclusion Criteria:

• Secondary gynecomastia caused by endocrine disorders, medications, hypogonadism, thyroid disease, or suspected malignancy.
• Pseudogynecomastia (lipomastia without glandular proliferation).
• Age younger than 18 years or older than 60 years.
• Severe uncontrolled comorbidities that may increase surgical risk.
• Previous chest or breast surgery, chest irradiation, or significant chest trauma.
• Active infection or coagulation disorder.
• Immunodeficiency disorders.
• Inability to provide informed consent.
• Inability to complete the planned follow-up period.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic NAC-Preserving Mastectomy Cohort; Adult male patients with gynecomastia undergoing endoscopic nipple-areola complex-preserving mastectomy as part of routine clinical care. Participants will be followed for 12 months to assess postoperative complications, nipple-areola complex sensation, scar quality, patient satisfaction, and quality of life.	Procedure: Endoscopic Nipple-Areola Complex-Preserving Mastectomy; The procedure is performed under general anesthesia using a minimally invasive endoscopic approach. Breast glandular tissue is removed through a small axillary incision while preserving the nipple-areola complex. Liposuction may be performed when clinically indicated. The surgical technique is performed as part of routine clinical care and is not assigned by the study.
Conventional Open NAC-Preserving Mastectomy Cohort; Adult male patients with gynecomastia undergoing conventional open nipple-areola complex-preserving mastectomy as part of routine clinical care. Participants will be followed for 12 months to assess postoperative complications, nipple-areola complex sensation, scar quality, patient satisfaction, and quality of life	Procedure: Conventional Open Nipple-Areola Complex-Preserving Mastectomy; The procedure is performed under general anesthesia using a conventional open surgical approach. Breast glandular tissue is removed through a periareolar incision while preserving the nipple-areola complex. Liposuction may be performed when clinically indicated. The surgical technique is performed as part of routine clinical care and is not assigned by the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient satisfaction assessed using the BODY-Q Chest Module following gynecomastia surgery	From enrollment through the 12-month follow-up period
Overall Postoperative Complication Rate	Incidence of postoperative complications including nipple-areola complex hypoesthesia, wound complications, hematoma, seroma, infection, contour deformity, and need for revision surgery	From enrollment through the 12-month follow-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar Quality	Scar quality assessed using the Vancouver Scar Scale (VSS)	From enrollment to the end of follow-up at 12 months
Nipple-Areola Complex Sensation	Sensory function of the nipple-areola complex assessed using the Semmes-Weinstein Monofilament Test (SWMT)	From enrollment to the end of follow-up at 12 months
Postoperative Pain	Patient-reported pain assessed using the Visual Analog Scale (VAS)	From enrollment to the end of follow-up at 12 months
Revision Surgery Rate	Incidence of revision surgical procedures required after the initial operation	From enrollment to the end of follow-up at 12 months

Collaborators and Investigators

• Sponsor: Antalya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2026
• Primary Completion (Estimated): January 8, 2027
• Study Completion (Estimated): January 8, 2028

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Gynecomastia
• Other Study ID Numbers: 175/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED