Comparison of Endoscopic and Open Surgery for Gynecomastia
12 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
De observación
Inscripción (Estimado)
100
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: MEHMET OLCUM
- Número de teléfono: +905388101828
- Correo electrónico: mehmetolcum@hotmail.com
Copia de seguridad de contactos de estudio
- Nombre: MERVE TOKOCİN
- Número de teléfono: +905356235594
- Correo electrónico: mervetokocin@gmail.com
Ubicaciones de estudio
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-
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Antalya, Turquía (Türkiye)
- Reclutamiento
- Antalya City Hospital
-
Contacto:
- Mehmet Olcum, MD
- Número de teléfono: +905388101828
- Correo electrónico: mehmetolcum@hotmail.com
-
Istanbul, Turquía (Türkiye)
- Reclutamiento
- Bagcilar Training and Research Hospital
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Contacto:
- Merve Tokocin, MD
- Número de teléfono: +905356235594
- Correo electrónico: mervetokocin@gmail.com
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient Satisfaction
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Scar Quality
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de enero de 2026
Finalización primaria (Estimado)
8 de enero de 2027
Finalización del estudio (Estimado)
8 de enero de 2028
Fechas de registro del estudio
Enviado por primera vez
12 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 175/2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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