- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07485309
Periareolar Excision vs Pull-Through in Gynecomastia
A Randomized Controlled Trial Comparing Periareolar Excision Versus Pull-Through Techniques in Simon Grade I-IIb Gynecomastia: A Phenotype-Dependent Outcome Analysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Gynecomastia is a benign proliferation of fibroglandular tissue in the male breast that alters chest contour and may significantly affect body image, confidence, and psychosocial well-being. Although many cases resolve spontaneously during adolescence, a proportion persist and require surgical correction. Multiple surgical techniques have been described, including traditional periareolar excision and minimally invasive approaches such as the pull-through technique combined with liposuction. However, consensus remains limited regarding the optimal surgical technique, particularly across different grades of gynecomastia severity.
This prospective randomized controlled trial was conducted at the Plastic Surgery Department, Faculty of Medicine, Kafr El-Sheikh University, Egypt, to compare outcomes between periareolar excision and the pull-through technique in patients with Simon Grade I-IIb gynecomastia. The study aimed to determine whether surgical effectiveness differs according to disease severity and tissue phenotype.
Sixty-four male patients aged 18-50 years with persistent gynecomastia were randomized in a 1:1 ratio to undergo either periareolar glandular excision or the pull-through technique following liposuction. Randomization was performed using a computer-generated sequence with allocation concealment through sealed opaque envelopes. All procedures were performed under general anesthesia on an outpatient basis.
The primary outcome was patient satisfaction measured at 6 months postoperatively using the Rasch-transformed BODY-Q Chest Module. Secondary outcomes included domain-level BODY-Q scores, objective anthropometric measurements, postoperative complications, recovery parameters (including time to return to work and hospital stay), glandular specimen weight, and blinded aesthetic evaluation based on standardized postoperative photographs assessed by independent plastic surgeons.
Statistical analysis included comparisons between groups and interaction analysis to determine whether treatment effects varied according to Simon grade. The study was designed to provide evidence supporting phenotype-based surgical decision-making in gynecomastia management.
This trial was retrospectively registered at ClinicalTrials.gov. The study was initiated prior to institutional establishment of a formal clinical trial registration pathway, and retrospective registration was completed to ensure transparency and compliance with international reporting standards.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kafr el-Sheikh Governorate
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Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt, 33516
- Kafr El-Sheikh University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male patients aged 18 to 50 years
- Clinically diagnosed Simon Grade I-IIb gynecomastia
- Persistent gynecomastia for more than 18 months
- Candidates for surgical correction under general anesthesia
- Provided written informed consent to participate in the study
Exclusion Criteria:
- Simon Grade III gynecomastia requiring skin excision
- Gynecomastia secondary to untreated endocrine disorders
- Chronic hepatic or renal disease
- Suspected or confirmed breast malignancy
- Previous gynecomastia surgery
- Active infection
- Coagulopathy or bleeding disorders
- Contraindications to general anesthesia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Periareolar Excision
Participants undergo gynecomastia correction using a semicircular inferior periareolar incision allowing direct glandular excision following liposuction.
A thin subareolar tissue layer is preserved to prevent nipple depression.
|
Surgical correction of gynecomastia using a semicircular inferior periareolar incision to allow direct glandular excision following liposuction.
A thin subareolar tissue layer is preserved to prevent nipple depression and maintain contour.
|
|
Active Comparator: Pull-Through Technique
Participants undergo minimally invasive gynecomastia correction using liposuction followed by glandular extraction through the liposuction incision using the pull-through technique with controlled traction and segmental excision.
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Minimally invasive surgical correction of gynecomastia using liposuction followed by glandular extraction through the liposuction incision using the pull-through technique with controlled traction and segmental excision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Patient Satisfaction (BODY-Q Chest Module)
Time Frame: 6 months postoperative
|
Patient-reported satisfaction with chest appearance measured using the Rasch-transformed BODY-Q Chest Module questionnaire.
Higher scores indicate greater satisfaction following gynecomastia surgery.
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6 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Domain-level BODY-Q Scores
Time Frame: 6 months postoperative
|
Assessment of specific BODY-Q domains including chest appearance, nipple aesthetics, and scar perception after gynecomastia surgery.
|
6 months postoperative
|
|
Change in Chest Anthropometric Measurements
Time Frame: Preoperative and 6 months postoperative
|
Change from baseline in chest anthropometric parameters including chest circumference, nipple-to-suprasternal notch distance, nipple-to-acromion distance, nipple-to-midclavicular distance, and breast projection, measured in centimeters (cm).
|
Preoperative and 6 months postoperative
|
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Number of Participants With Postoperative Complications
Time Frame: Within 6 months postoperative
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Number of participants experiencing postoperative complications including hematoma, seroma, infection, or need for revision surgery.
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Within 6 months postoperative
|
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Length of Postoperative Hospital Stay
Time Frame: Within 30 days postoperative
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Duration of hospital stay following gynecomastia surgery, measured in days.
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Within 30 days postoperative
|
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Postoperative Pain Score
Time Frame: Postoperative day 1
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Postoperative pain assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain.
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Postoperative day 1
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Time to Return to Work
Time Frame: Up to 6 months postoperative
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Time from surgery to return to normal work or daily activities, measured in days.
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Up to 6 months postoperative
|
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Blinded Surgeon Aesthetic Evaluation Score
Time Frame: 6 months postoperative
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Independent aesthetic evaluation of postoperative chest contour using standardized postoperative photographs assessed by board-certified plastic surgeons blinded to treatment allocation.
Aesthetic outcome will be rated using a 5-point Likert scale, where 1 indicates a very poor aesthetic outcome and 5 indicates excellent aesthetic outcome.
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6 months postoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: asem Elkot, MD, Plastic Surgery Department, Faculty of Medicine, Kafr El-Sheikh University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-335
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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