Long Term Follow-up for Hypospadias. Hypospadias KOK
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Event Free Survival
研究概览
简要总结
Hypospadias is a frequent malformation. The definition of hypospadias is a ventral tissues hypoplasia, with an abnormal position of the urethral meatus, a chordee of the penis and an open foreskin. It can be associate with other genital malformation; in that case it can be classified in the wider field of the disorder of sex development (DSD). There is a lot of surgical technics for those malformations.
In the pediatric surgical department, in Lyon, three technics are the most used because of their reliability and their good outcomes in short and mid term.
This is essential for investigator to have a long term evaluation, with a physical exam and paraclinical exams, after the puberty, to assess the outcomes after the changes especially at the puberty.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients
- •with previous hypospadias surgery,
- •Birthday before December the 31th
- •The surgery was performed by one operator, with the following surgical technics: Koff, Onlay and Koyanagi.
- •The patients are informed by an official surgery department letter, to assure they agree to participate.
- •if the patient is still an infant, the parental agreement will be necessary.
排除标准
- •Patient deceased
- •Non- agreement from the patient or his parents
- •Language difficulties
研究组 & 干预措施
long term evaluation of hypospadias surgery
干预措施: clinical and paraclinical examination (Procedure)
结局指标
主要结局
Event Free Survival
时间窗: Day 0
Time with no complication after the last surgery for hypospadias
次要结局
- patient satisfaction(day 0)
- Penis size(Day 0)
- Urinary symptoms(Day 0)
- quality of the urinary flow: straight or not straight(Day 0)
- sexual activity(Day 0)
- occurrence of urinary infection(Day 0)
- Pre-voiding bladder volume(Day 0)
- post-voiding bladder volume(Day 0)
- Flow measurement(Day 0)
- occurrence of ejaculation(Day 0)
- occurrence of erection(Day 0)
- puberty clinical signs(Day 0)
- endocrine disorder(Day 0)
- Testicular ultrasonography(day 0)