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临床试验/NCT03593720
NCT03593720已完成不适用

Glans Size in Hypospadias Compared to Normal

Albany Medical College1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2018年7月25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
410
试验地点
1
主要终点
Difference in glans size between hypospadias patients and those without hypospadias

研究概览

简要总结

The investigator will collect data on penile and glans size by age, weight and ethnicity in both patients undergoing routine urological surgery and hypospadias surgery.

详细描述

After obtaining informed consent , the investigator will measure stretched penile length and glans size in 3 dimensions (length, width, height) in the office on patients with hypospadias, as well as at the time of operation, after the induction of anesthesia. Patients undergoing hypospadias surgery will be considered study subjects. If the patient was given pre-operative testosterone as part of the current standard of care, this will be noted and the measurements taken at each pre-operative office visit will be recorded. The investigator will also record corrected age, weight in kilograms and ethnicity as identified by the family.

Control patients will be those male patients undergoing non-hypospadias urological surgery (hernia repair, orchiopexy, circumcision, re-circumcision) with a normal penis, the investigator will perform a single intra-operative measurement of the same glans and penile variables after induction of anesthesia and prior to the start of their genital surgery. Again, age, weight and ethnicity will be recorded.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
Male
接受健康志愿者

入选标准

  • Patients undergoing surgery for hypospadias
  • Patients undergoing any urologic surgery other than hypospadias

排除标准

  • other penile abnormalities (Hidden penis, penoscrotal wedding/transposition, chordee without hypospadias, penile torsion, etc.)
  • Undergoing other penile procedures (penoplasty, chordee repair, penile detorsion, etc.)

结局指标

主要结局

Difference in glans size between hypospadias patients and those without hypospadias

时间窗: 6 months

The investigator will prospectively collect data on glans size by age, weight and ethnicity in both patients undergoing routine urological surgery and hypospadias surgery

次要结局

  • Difference in penile length between hypospadias patients and those without hypospadias(6 months)
  • Determine the effect of testosterone on penile and glans growth in hypospadias(24 months)
  • Track penile and glans growth curves in both cohorts(24 months)

研究者

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

Barry Kogan, MD

Professor of Surgery and Pediatrics

Albany Medical College

研究点 (1)

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