GynecomastiaNCT07653152
Comparison of Endoscopic and Open Surgery for Gynecomastia
An observational study of Gynecomastia, run by Antalya City Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Gynecomastia
- What is being tested?
- Endoscopic Nipple-Areola Complex-Preserving Mastectomy and Conventional Open Nipple-Areola Complex-Preserving Mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 8 Jan 2026to 8 Jan 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Immunodeficiency disorders.
- Inability to provide informed consent.
- Inability to complete the planned follow-up period.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Antalya City Hospital
Antalya
Mehmet Olcum, MD, +905388101828, mehmetolcum@hotmail.com
- Recruiting
Bagcilar Training and Research Hospital
Istanbul
Merve Tokocin, MD, +905356235594, mervetokocin@gmail.com
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Gynecomastia
- Being tested
- Endoscopic Nipple-Areola Complex-Preserving Mastectomy, Conventional Open Nipple-Areola Complex-Preserving Mastectomy
- Medical subject headings
- Gynecomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Nipple-Areola Complex-Preserving MastectomyProcedure or surgery
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 MastectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Conventional Open Nipple-Areola Complex-Preserving Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient satisfaction assessed using the BODY-Q Chest Module following gynecomastia surgery
Measured: 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
Measured: From enrollment through the 12-month follow-up period
Secondary outcomes (4)
Scar Quality
Scar quality assessed using the Vancouver Scar Scale (VSS)
Measured: 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)
Measured: From enrollment to the end of follow-up at 12 months
Postoperative Pain
Patient-reported pain assessed using the Visual Analog Scale (VAS)
Measured: From enrollment to the end of follow-up at 12 months
Revision Surgery Rate
Incidence of revision surgical procedures required after the initial operation
Measured: From enrollment to the end of follow-up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start8 Jan 2026
- Primary completion8 Jan 2027 (estimated)
- Study completion8 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecomastiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Antalya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653152
- Sponsor's protocol ID
- 175/2025
- Status last verified
- May 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Evaluation of Different Surgical Techniques in the Treatment of Gynecomastia: A Multicenter Study
- ClinicalTrials.gov ID
- NCT07653152
- Acronym / sponsor ID
- 175/2025
- Conditions
- Gynecomastia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Antalya City HospitalUniversity, hospital or other
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 8 Jan 2027 (estimated)
- Study completion
- 8 Jan 2028 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic NAC-Preserving Mastectomy Cohort | – | Procedure: Endoscopic Nipple-Areola Complex-Preserving MastectomyAdult 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. |
| Conventional Open NAC-Preserving Mastectomy Cohort | – | Procedure: Conventional Open Nipple-Areola Complex-Preserving MastectomyAdult 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Nipple-Areola Complex-Preserving MastectomyThe 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 or surgery | Endoscopic NAC-Preserving Mastectomy Cohort |
| Conventional Open Nipple-Areola Complex-Preserving MastectomyThe 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. | Procedure or surgery | Conventional Open NAC-Preserving Mastectomy Cohort |
Primary outcome
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
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Gynecomastia
Recruiting
Determining INdividual Preferences for Gynecomastia avOidance (DINGO) - Stage 1
Prostate Cancer (Adenocarcinoma)
Not yet recruiting
To Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection in Males
Gynecomastia
Active, not recruitingObservational study
A Clinical Effectiveness Study of Total Laparoscopic Subcutaneous Gland Resection Combined With Nipple-Areola Complex Lift in the Management of Moderate to Severe Gynecomastia in Males
Gynecomastia
Not yet recruiting
Modularities of Management of Severe Grades of Gynecomastia.
Gynecomastia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecomastia, run by Antalya City Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MEHMET OLCUM (+905388101828, mehmetolcum@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: From enrollment through the 12-month follow-up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.