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Идёт набор NCT07653152

Comparison of Endoscopic and Open Surgery for Gynecomastia

— Наблюдательное Gynecomastia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Endoscopic Nipple-Areola Complex-Preserving Mastectomy, Conventional Open Nipple-Areola Complex-Preserving Mastectomy.
Кому может быть актуально
Состояния в реестре: Gynecomastia. Базовые параметры: 18 лет — 60 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Процедура Endoscopic Nipple-Areola Complex-Preserving Mastectomy
    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.
  • Процедура Conventional Open Nipple-Areola Complex-Preserving Mastectomy
    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.

Первичные конечные точки

  • Patient Satisfaction [Срок оценки: From enrollment through the 12-month follow-up period]
  • Overall Postoperative Complication Rate [Срок оценки: From enrollment through the 12-month follow-up period]
Вторичные конечные точки (4)
  • Scar Quality [Срок оценки: From enrollment to the end of follow-up at 12 months]
  • Nipple-Areola Complex Sensation [Срок оценки: From enrollment to the end of follow-up at 12 months]
  • Postoperative Pain [Срок оценки: From enrollment to the end of follow-up at 12 months]
  • Revision Surgery Rate [Срок оценки: From enrollment to the end of follow-up at 12 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 2 центра
  • Antalya City Hospital — Antalya
  • Bagcilar Training and Research Hospital — Istanbul

Идентификаторы

NCT: NCT07653152 · 175/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗