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临床试验/NCT07653152
NCT07653152招募中不适用

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

Antalya City Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
Antalya City Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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