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Comparison of Endoscopic and Open Surgery for Gynecomastia

12 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Turquie (Türkiye)
      • Antalya, Turquie (Türkiye)
        • Recrutement
        • Antalya City Hospital
        • Contact:
      • Istanbul, Turquie (Türkiye)
        • Recrutement
        • Bagcilar Training and Research Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Procédure: 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.
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
Procédure: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Patient Satisfaction
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Scar Quality
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Antalya City Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

8 janvier 2026

Achèvement primaire (Estimé)

8 janvier 2027

Achèvement de l'étude (Estimé)

8 janvier 2028

Dates d'inscription aux études

Première soumission

12 juin 2026

Première soumission répondant aux critères de contrôle qualité

12 juin 2026

Première publication (Réel)

17 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 175/2025

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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