Comparison of Endoscopic and Open Surgery for Gynecomastia
12. juni 2026 oppdatert 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.
Studieoversikt
Status
Rekruttering
Forhold
Studietype
Observasjonsmessig
Registrering (Antatt)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: MEHMET OLCUM
- Telefonnummer: +905388101828
- E-post: mehmetolcum@hotmail.com
Studer Kontakt Backup
- Navn: MERVE TOKOCİN
- Telefonnummer: +905356235594
- E-post: mervetokocin@gmail.com
Studiesteder
-
-
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Antalya, Tyrkia (Türkiye)
- Rekruttering
- Antalya City Hospital
-
Ta kontakt med:
- Mehmet Olcum, MD
- Telefonnummer: +905388101828
- E-post: mehmetolcum@hotmail.com
-
Istanbul, Tyrkia (Türkiye)
- Rekruttering
- Bagcilar Training and Research Hospital
-
Ta kontakt med:
- Merve Tokocin, MD
- Telefonnummer: +905356235594
- E-post: mervetokocin@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient Satisfaction
Tidsramme: 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
Tidsramme: From enrollment through the 12-month follow-up period
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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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Scar Quality
Tidsramme: From enrollment to the end of follow-up at 12 months
|
Scar quality assessed using the Vancouver Scar Scale (VSS)
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From enrollment to the end of follow-up at 12 months
|
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Nipple-Areola Complex Sensation
Tidsramme: 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
|
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Postoperative Pain
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. januar 2026
Primær fullføring (Antatt)
8. januar 2027
Studiet fullført (Antatt)
8. januar 2028
Datoer for studieregistrering
Først innsendt
12. juni 2026
Først innsendt som oppfylte QC-kriteriene
12. juni 2026
Først lagt ut (Faktiske)
17. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 175/2025
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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