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Comparison of Endoscopic and Open Surgery for Gynecomastia

12 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Turkiet (Türkiye)
      • Antalya, Turkiet (Türkiye)
        • Rekrytering
        • Antalya City Hospital
        • Kontakt:
      • Istanbul, Turkiet (Türkiye)
        • Rekrytering
        • Bagcilar Training and Research Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Procedur: 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
Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patient Satisfaction
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Scar Quality
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Antalya City Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 januari 2026

Primärt slutförande (Beräknad)

8 januari 2027

Avslutad studie (Beräknad)

8 januari 2028

Studieregistreringsdatum

Först inskickad

12 juni 2026

Först inskickad som uppfyllde QC-kriterierna

12 juni 2026

Första postat (Faktisk)

17 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 juni 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 175/2025

Plan för individuella deltagardata (IPD)

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OBESLUTSAM

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