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Comparison of Endoscopic and Open Surgery for Gynecomastia

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07653152
Enrollment
100
Registered
2026-06-17
Start date
2026-01-08
Completion date
2028-01-08
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecomastia

Brief summary

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

PROCEDUREEndoscopic 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.

PROCEDUREConventional 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.

Sponsors

Antalya City Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient SatisfactionFrom enrollment through the 12-month follow-up periodPatient satisfaction assessed using the BODY-Q Chest Module following gynecomastia surgery
Overall Postoperative Complication RateFrom enrollment through the 12-month follow-up periodIncidence of postoperative complications including nipple-areola complex hypoesthesia, wound complications, hematoma, seroma, infection, contour deformity, and need for revision surgery

Secondary

MeasureTime frameDescription
Scar QualityFrom enrollment to the end of follow-up at 12 monthsScar quality assessed using the Vancouver Scar Scale (VSS)
Nipple-Areola Complex SensationFrom enrollment to the end of follow-up at 12 monthsSensory function of the nipple-areola complex assessed using the Semmes-Weinstein Monofilament Test (SWMT)
Postoperative PainFrom enrollment to the end of follow-up at 12 monthsPatient-reported pain assessed using the Visual Analog Scale (VAS)
Revision Surgery RateFrom enrollment to the end of follow-up at 12 monthsIncidence of revision surgical procedures required after the initial operation

Countries

Turkey (Türkiye)

Contacts

CONTACTMEHMET OLCUM
mehmetolcum@hotmail.com+905388101828
CONTACTMERVE TOKOCİN
mervetokocin@gmail.com+905356235594

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026