Periareolar Excision vs Pull-Through in Gynecomastia

NCT07485309 | Completed

• 1 other identifier: KFSIRB200-335
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gynecomastia

Keywords

Gynecomastia Surgery; Periareolar Excision; Pull-through Technique; Simon Classification; BODY-Q; Chest Contouring

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months postoperative

Secondary Outcomes (7)

• Domain-level BODY-Q Scores

  6 months postoperative

• Change in Chest Anthropometric Measurements

  Preoperative and 6 months postoperative

• Number of Participants With Postoperative Complications

  Within 6 months postoperative

• Length of Postoperative Hospital Stay

  Within 30 days postoperative

• Postoperative Pain Score

  Postoperative day 1

Study Arms (2)

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.

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.

Procedure: Pull-Through Technique

Interventions

Periareolar Excision PROCEDURE

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.

Periareolar Excision

Pull-Through Technique PROCEDURE

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.

Pull-Through Technique

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr El-Sheikh University Hospital

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt

Location

MeSH Terms

Conditions

Gynecomastia

Condition Hierarchy (Ancestors)

Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• asem Elkot, MD

  Plastic Surgery Department, Faculty of Medicine, Kafr El-Sheikh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were blinded to the surgical technique performed. Postoperative aesthetic outcomes were evaluated using standardized photographs assessed by independent board-certified plastic surgeons who were blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of general surgery department

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 20, 2026
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)