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临床试验/NCT07485309
NCT07485309已完成不适用

A Randomized Controlled Trial Comparing Periareolar Excision Versus Pull-Through Techniques in Simon Grade I-IIb Gynecomastia: A Phenotype-Dependent Outcome Analysis

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Total Patient Satisfaction (BODY-Q Chest Module)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Total Patient Satisfaction (BODY-Q Chest Module)

时间窗: 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.

次要结局

  • Time to Return to Work(Up to 6 months postoperative)
  • 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)
  • Blinded Surgeon Aesthetic Evaluation Score(6 months postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Aouf

lecturer of general surgery department

Kafrelsheikh University

研究点 (1)

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