NCT07653152

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Jan 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jan 2026Jan 2028

Study Start

First participant enrolled

January 8, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2028

Last Updated

June 17, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

Gynecomastia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Scar Quality

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

  • Nipple-Areola Complex Sensation

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

  • Postoperative Pain

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

  • Revision Surgery Rate

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

Study Arms (2)

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

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

Interventions

Endoscopic Nipple-Areola Complex-Preserving MastectomyPROCEDURE

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.

Endoscopic NAC-Preserving Mastectomy Cohort
Conventional Open Nipple-Areola Complex-Preserving MastectomyPROCEDURE

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.

Conventional Open NAC-Preserving Mastectomy Cohort

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Antalya City Hospital

Antalya, Turkey (Türkiye)

RECRUITING

Bagcilar Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Gynecomastia

Condition Hierarchy (Ancestors)

Breast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

MEHMET OLCUM

CONTACT

+905388101828mehmetolcum@hotmail.com

MERVE TOKOCİN

CONTACT

+905356235594mervetokocin@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start

January 8, 2026

Primary Completion (Estimated)

January 8, 2027

Study Completion (Estimated)

January 8, 2028

Last Updated

June 17, 2026

Record last verified: 2026-05

Locations

TU(2)