Internal Spermatic Vein Histopathology and Its Relationships With Clinical, Laboratory, and Duplex Ultrasound Parameters in Patients Undergoing Varicocelectomy: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Correlation of Internal Spermatic Vein Histopathological Parameters With Clinical, Duplex Ultrasound, and Semen Parameters
研究概览
简要总结
Varicocele is an enlargement of the veins around the testicle and may affect male fertility. This prospective observational study will include men with varicocele who are undergoing varicocelectomy. The study aims to examine whether changes in the structure of the internal spermatic veins are related to clinical findings, semen analysis results, and scrotal duplex ultrasound findings.
During varicocelectomy, vein tissue that is removed as part of the surgical procedure will be collected and examined under a microscope. Digital image analysis will also be used to measure different features of the vein wall, including its thickness and the amounts of smooth muscle and collagen.
In participants undergoing surgery for varicocele on both sides, the findings from the left and right spermatic veins will also be compared. The study does not assign participants to varicocelectomy; the decision to perform surgery is based on their clinical care.
详细描述
This prospective cohort study will include male patients with clinically palpable varicocele who are scheduled to undergo varicocelectomy at Assiut University Hospitals.
Preoperative assessment will include clinical evaluation, semen analysis, and scrotal duplex ultrasonography. Clinical assessment will include age, laterality, and clinical varicocele grade. Semen parameters will include semen volume, sperm concentration, total sperm count, progressive motility, non-progressive motility, and sperm morphology. Duplex ultrasound assessment will include right and left testicular volume, maximum spermatic vein diameter, presence of venous reflux, and reflux duration.
Internal spermatic vein specimens excised during varicocelectomy will undergo histopathological and digital morphometric assessment. Specimens will be routinely processed and stained with hematoxylin and eosin and Masson's trichrome. Digital morphometric analysis will be performed using QuPath to quantitatively assess total venous wall area, wall thickness, wall-thickness-to-lumen-diameter ratio, smooth-muscle area, collagen area, and muscle-to-collagen ratio.
The relationships between these histopathological measurements and clinical characteristics, duplex ultrasound findings, and semen parameters will be evaluated. In participants with bilateral varicocele undergoing bilateral varicocelectomy, left and right spermatic vein specimens will be assessed separately to allow paired comparison of histopathological and quantitative morphometric findings and their relationships with corresponding side-specific clinical and duplex ultrasound findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients with clinically palpable varicocele.
- •Scheduled for varicocelectomy.
- •Preoperative scrotal duplex ultrasonography available.
- •Preoperative semen analysis available.
- •Written informed consent for participation.
排除标准
- •Previous varicocelectomy on the affected side.
- •Previous major scrotal or testicular surgery affecting the study side.
- •Obstructive causes of azoospermia, when applicable to the semen analysis component.
- •Hormonal treatment that may significantly alter semen parameters.
- •Incomplete clinical, duplex ultrasound, or semen analysis data.
- •Declines participation.
结局指标
主要结局
Correlation of Internal Spermatic Vein Histopathological Parameters With Clinical, Duplex Ultrasound, and Semen Parameters
时间窗: Preoperatively and at the time of varicocelectomy
Internal spermatic vein histopathological parameters will be quantified using QuPath digital morphometric analysis and correlated with prespecified clinical, duplex ultrasound, and semen parameters using Pearson or Spearman correlation, as appropriate. Histopathological parameters include total wall area, wall thickness, wall-thickness-to-lumen-diameter ratio, smooth muscle area (% of wall and % of media), collagen area (% of wall and % of adventitia), and muscle-to-collagen ratio.
次要结局
未报告次要终点
研究者
Khaled Maged Fathy Mahmoud
Resident at Andrology, Sexology and STDs department
Assiut University