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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Scar Quality | Scar quality assessed using the Vancouver Scar Scale (VSS) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MEHMET OLCUM | Contact | +905388101828 | mehmetolcum@hotmail.com | |
| MERVE TOKOCİN | Contact | +905356235594 | mervetokocin@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antalya City Hospital | Recruiting | Antalya | Turkey (Türkiye) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 8, 2026 | Jun 3, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D006177 | Gynecomastia |
| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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. |
|
| From enrollment to the end of follow-up at 12 months |
| Postoperative Pain | Patient-reported pain assessed using the Visual Analog Scale (VAS) | From enrollment to the end of follow-up at 12 months |
| Revision Surgery Rate | Incidence of revision surgical procedures required after the initial operation | From enrollment to the end of follow-up at 12 months |
| Bagcilar Training and Research Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
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