Comparison of Endoscopic and Open Surgery for Gynecomastia
2026年6月12日 更新者：Antalya City Hospital
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:
- 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.
研究概览
地位
招聘中
条件
研究类型
观察性的
注册 (估计的)
100
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：MEHMET OLCUM
- 电话号码：+905388101828
- 邮箱：mehmetolcum@hotmail.com
研究联系人备份
- 姓名：MERVE TOKOCİN
- 电话号码：+905356235594
- 邮箱：mervetokocin@gmail.com
学习地点
-
-
-
Antalya、土耳其（türkiye）
- 招聘中
- Antalya City Hospital
-
接触：
- Mehmet Olcum, MD
- 电话号码：+905388101828
- 邮箱：mehmetolcum@hotmail.com
-
Istanbul、土耳其（türkiye）
- 招聘中
- Bagcilar Training and Research Hospital
-
接触：
- Merve Tokocin, MD
- 电话号码：+905356235594
- 邮箱：mervetokocin@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
取样方法
非概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
|
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 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
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Satisfaction
大体时间：From enrollment through the 12-month follow-up period
|
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
大体时间：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
|
From enrollment through the 12-month follow-up period
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Scar Quality
大体时间：From enrollment to the end of follow-up at 12 months
|
Scar quality assessed using the Vancouver Scar Scale (VSS)
|
From enrollment to the end of follow-up at 12 months
|
|
Nipple-Areola Complex Sensation
大体时间：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)
|
From enrollment to the end of follow-up at 12 months
|
|
Postoperative Pain
大体时间：From enrollment to the end of follow-up at 12 months
|
Patient-reported pain assessed using the Visual Analog Scale (VAS)
|
From enrollment to the end of follow-up at 12 months
|
|
Revision Surgery Rate
大体时间：From enrollment to the end of follow-up at 12 months
|
Incidence of revision surgical procedures required after the initial operation
|
From enrollment to the end of follow-up at 12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月8日
初级完成 (估计的)
2027年1月8日
研究完成 (估计的)
2028年1月8日
研究注册日期
首次提交
2026年6月12日
首先提交符合 QC 标准的
2026年6月12日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年6月17日
上次提交的符合 QC 标准的更新
2026年6月12日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.