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Recruiting NCT07653152

Comparison of Endoscopic and Open Surgery for Gynecomastia

— Observational Gynecomastia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic Nipple-Areola Complex-Preserving Mastectomy, Conventional Open Nipple-Areola Complex-Preserving Mastectomy.
Who it may be relevant to
Registry conditions: Gynecomastia. Basic parameters: 18 years — 60 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Patient Satisfaction [Time frame: From enrollment through the 12-month follow-up period]
  • Overall Postoperative Complication Rate [Time frame: From enrollment through the 12-month follow-up period]
Secondary outcome measures (4)
  • Scar Quality [Time frame: From enrollment to the end of follow-up at 12 months]
  • Nipple-Areola Complex Sensation [Time frame: From enrollment to the end of follow-up at 12 months]
  • Postoperative Pain [Time frame: From enrollment to the end of follow-up at 12 months]
  • Revision Surgery Rate [Time frame: From enrollment to the end of follow-up at 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 2 centers
  • Antalya City Hospital — Antalya
  • Bagcilar Training and Research Hospital — Istanbul

Identifiers

NCT: NCT07653152 · 175/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗