Comparison of Endoscopic and Open Surgery for Gynecomastia
ConditionGynecomastia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-60
SponsorAntalya City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Endoscopic Nipple-Areola Complex-Preserving Mastectomy
Procedure/SurgeryThe 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 Nipple-Areola Complex-Preserving Mastectomy
Procedure/SurgeryThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Endoscopic NAC-Preserving Mastectomy Cohort1 intervention
Group B: Conventional Open NAC-Preserving Mastectomy Cohort1 intervention
Trial outcomes
Primary outcomes
1
Patient Satisfaction
Patient satisfaction assessed using the BODY-Q Chest Module following gynecomastia surgery
Time frame
From enrollment through the 12-month follow-up period2
Overall Postoperative Complication Rate
Incidence of postoperative complications including nipple-areola complex hypoesthesia, wound complications, hematoma, seroma, infection, contour deformity, and need for revision surgery
Time frame
From enrollment through the 12-month follow-up periodSecondary outcomes
1
Scar Quality
Scar quality assessed using the Vancouver Scar Scale (VSS)
Time frame
From enrollment to the end of follow-up at 12 months2
Nipple-Areola Complex Sensation
Sensory function of the nipple-areola complex assessed using the Semmes-Weinstein Monofilament Test (SWMT)
Time frame
From enrollment to the end of follow-up at 12 months3
Postoperative Pain
Patient-reported pain assessed using the Visual Analog Scale (VAS)
Time frame
From enrollment to the end of follow-up at 12 months4
Revision Surgery Rate
Incidence of revision surgical procedures required after the initial operation
Time frame
From enrollment to the end of follow-up at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov