GynecomastiaNCT07485309
Periareolar Excision vs Pull-Through in Gynecomastia
A study testing Periareolar Excision and Pull-Through Technique in people with Gynecomastia, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This prospective randomized controlled trial compares periareolar excision and pull-through techniques in 64 patients with Simon Grade I-IIb gynecomastia. Patients were randomized 1:1 and followed for 6 months. The primary outcome was total patient satisfaction measured using the Rasch-transformed BODY-Q Chest Module. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Gynecomastia
- What is being tested?
- Periareolar Excision and Pull-Through Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafr El-Sheikh University Hospital
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516
About this study
Official title: A Randomized Controlled Trial Comparing Periareolar Excision Versus Pull-Through Techniques in Simon Grade I-IIb Gynecomastia: A Phenotype-Dependent Outcome Analysis
This prospective randomized controlled trial compares periareolar excision and pull-through techniques in 64 patients with Simon Grade I-IIb gynecomastia. Patients were randomized 1:1 and followed for 6 months. The primary outcome was total patient satisfaction measured using the Rasch-transformed BODY-Q Chest Module. Secondary outcomes included anthropometric measurements, recovery parameters, complication rates, and blinded aesthetic evaluation. A formal interaction analysis assessed whether surgical superiority differed according to disease severity.
Read the 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.
- Conditions
- Gynecomastia
- Being tested
- Periareolar Excision, Pull-Through Technique
- Keywords
- Gynecomastia Surgery, Periareolar Excision, Pull-through Technique, Simon Classification, BODY-Q, Chest Contouring
- Medical subject headings
- Gynecomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periareolar ExcisionProcedure or surgery
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.
Pull-Through TechniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Periareolar Excision | Active comparator | 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. Receives: Procedure: Periareolar Excision |
| Pull-Through Technique | Active comparator | 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. Receives: Procedure: Pull-Through Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Patient Satisfaction (BODY-Q Chest Module)
Patient-reported satisfaction with chest appearance measured using the Rasch-transformed BODY-Q Chest Module questionnaire. Higher scores indicate greater satisfaction following gynecomastia surgery.
Measured: 6 months postoperative
Secondary outcomes (7)
Domain-level BODY-Q Scores
Assessment of specific BODY-Q domains including chest appearance, nipple aesthetics, and scar perception after gynecomastia surgery.
Measured: 6 months postoperative
Change in Chest Anthropometric Measurements
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).
Measured: Preoperative and 6 months postoperative
Number of Participants With Postoperative Complications
Number of participants experiencing postoperative complications including hematoma, seroma, infection, or need for revision surgery.
Measured: Within 6 months postoperative
Length of Postoperative Hospital Stay
Duration of hospital stay following gynecomastia surgery, measured in days.
Measured: Within 30 days postoperative
Postoperative Pain Score
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.
Measured: Postoperative day 1
Time to Return to Work
Time from surgery to return to normal work or daily activities, measured in days.
Measured: Up to 6 months postoperative
Blinded Surgeon Aesthetic Evaluation Score
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.
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Sep 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecomastiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with Simon Grade I-IIb gynecomastia were randomized in a 1:1 ratio to undergo either periareolar excision or pull-through technique. Outcomes were compared between parallel groups over a 6-month follow-up period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Aouf, Kafrelsheikh University
- Investigators
- asem Elkot, MD, Principal investigator, Plastic Surgery Department, Faculty of Medicine, Kafr El-Sheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485309
- Sponsor's protocol ID
- KFSIRB200-335
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared. Data may be available from the corresponding investigator upon reasonable request and with appropriate institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Periareolar Excision Versus Pull-Through Techniques in Simon Grade I-IIb Gynecomastia: A Phenotype-Dependent Outcome Analysis
- ClinicalTrials.gov ID
- NCT07485309
- Acronym / sponsor ID
- KFSIRB200-335
- Conditions
- Gynecomastia
- Keywords
- Gynecomastia Surgery, Periareolar Excision, Pull-through Technique, Simon Classification, BODY-Q, Chest Contouring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized controlled trial compares periareolar excision and pull-through techniques in 64 patients with Simon Grade I-IIb gynecomastia. Patients were randomized 1:1 and followed for 6 months. The primary outcome was total patient satisfaction measured using the Rasch-transformed BODY-Q Chest Module. Secondary outcomes included anthropometric measurements, recovery parameters, complication rates, and blinded aesthetic evaluation. A formal interaction analysis assessed whether surgical superiority differed according to disease severity.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants with Simon Grade I-IIb gynecomastia were randomized in a 1:1 ratio to undergo either periareolar excision or pull-through technique. Outcomes were compared between parallel groups over a 6-month follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Periareolar Excision | Active comparator | Procedure: Periareolar ExcisionParticipants 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. |
| Pull-Through Technique | Active comparator | Procedure: Pull-Through TechniqueParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periareolar ExcisionSurgical 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. | Procedure or surgery | Periareolar Excision |
| Pull-Through TechniqueMinimally 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. | Procedure or surgery | Pull-Through Technique |
Primary outcome
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.
7 secondary outcomes
Domain-level BODY-Q Scores
Time frame: 6 months postoperative
Change in Chest Anthropometric Measurements
Time frame: Preoperative and 6 months postoperative
Number of Participants With Postoperative Complications
Time frame: Within 6 months postoperative
Length of Postoperative Hospital Stay
Time frame: Within 30 days postoperative
Postoperative Pain Score
Time frame: Postoperative day 1
Time to Return to Work
Time frame: Up to 6 months postoperative
Blinded Surgeon Aesthetic Evaluation Score
Time frame: 6 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared. Data may be available from the corresponding investigator upon reasonable request and with appropriate institutional approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
asem Elkot, MD principal investigator
Plastic Surgery Department, Faculty of Medicine, Kafr El-Sheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periareolar Excision and Pull-Through Technique in people with Gynecomastia, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Patient Satisfaction (BODY-Q Chest Module) (time frame: 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.