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NCT Number: NCT07653152

Comparison of Endoscopic and Open Surgery for Gynecomastia

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.

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Key information

Conditions

Gynecomastia Breast Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Antalya City Hospital, Antalya, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic Nipple-Areola Complex-Preserving Mastectomy

Procedure

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 Nipple-Areola Complex-Preserving Mastectomy

Procedure

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 outcomes

  1. Patient Satisfaction

    Time frame: From enrollment through the 12-month follow-up period

    Patient satisfaction assessed using the BODY-Q Chest Module following gynecomastia surgery

  2. Overall Postoperative Complication Rate

    Time frame: From enrollment through the 12-month follow-up period

    Incidence of postoperative complications including nipple-areola complex hypoesthesia, wound complications, hematoma, seroma, infection, contour deformity, and need for revision surgery

Secondary outcomes

  1. Scar Quality

    Time frame: From enrollment to the end of follow-up at 12 months

    Scar quality assessed using the Vancouver Scar Scale (VSS)

  2. Nipple-Areola Complex Sensation

    Time frame: From enrollment to the end of follow-up at 12 months

    Sensory function of the nipple-areola complex assessed using the Semmes-Weinstein Monofilament Test (SWMT)

  3. Postoperative Pain

    Time frame: From enrollment to the end of follow-up at 12 months

    Patient-reported pain assessed using the Visual Analog Scale (VAS)

  4. Revision Surgery Rate

    Time frame: From enrollment to the end of follow-up at 12 months

    Incidence of revision surgical procedures required after the initial operation

Study contacts

Contact information is provided by the study sponsor or research team.

MEHMET OLCUM

CONTACT

[email protected]

+905388101828

MERVE TOKOCİN

CONTACT

[email protected]

+905356235594

Sponsors and collaborators

Lead sponsor

Antalya City Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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