Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 4
- 主要终点
- Number of patient with postoperative urethral fistula and dehiscence
研究概览
简要总结
Hypospadias is a congenital abnormality of the penis that is caused by incomplete development of the anterior urethra. This pathology is one of the most common genital anomalies in paediatric urology .The incidence is reported to be 1 out of 250 live male births and is increasing regularly. The hypospadias surgeries present a high risk of post operative complications requiring re-interventions.
A great part of the post operative complications is related to imperfect healing issues. If androgen stimulation seems to be deleterious, at the opposite, oestrogen could impact positively on the skin healing process. This point leads to the hypothesis that local transcutaneous oestrogen stimulation on the ventral and dorsal penile faces decreases the number of skin healing post-operative defects.
The objective of the study is to assess the effect of oestrogen (applied once daily for 2 months prior to surgery) on the post-operative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Months 至 36 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Severe hypospadias with a division of the corpus spongiosum behind the midshaft of the penis and for which repair requires a urethral substitution by onlay urethroplasty.
- •Subjects operated between 9 and 36 months old.
- •Subjects operated in one of the departments of paediatric urology involved in the study.
- •Surgery performed by a surgeon with at least 5 years of practical experience in the hypospadias surgery.
- •Written informed consent obtained from parents or legal guardians prior to the participation to the study
- •All hypospadias aetiology (hormonal, karyotype or genetic)
排除标准
- •Refusal to participate
- •Subjects with glandular hypospadias
- •Subjects aged <9 months or > 36months old at time of surgery.
- •Subjects who had prior surgery of penis (circumcision or hypospadias surgery)
- •Subjects treated with androgens (Human Chorionic Gonadotrophin or delayed testosterone) within 6 months prior to surgery.
- •Intolerance to promestriene or its excipients.
- •Not affiliated to a healthy or social security cover.
- •Known tumoral risk
- •Pure or mixed gonadal dysgenesis (45, X0/46,XY)
研究组 & 干预措施
promestriene
Children with severe hypospadias treated with promestriene 1%
干预措施: Wrist X ray (Radiation)
promestriene
Children with severe hypospadias treated with promestriene 1%
干预措施: promestriene (Drug)
promestriene
Children with severe hypospadias treated with promestriene 1%
干预措施: Urethroplasty (Procedure)
promestriene
Children with severe hypospadias treated with promestriene 1%
干预措施: Blood test (Procedure)
Placebo
Control group, children with severe hypospadias treated with Placebo.
干预措施: Placebo (Drug)
Placebo
Control group, children with severe hypospadias treated with Placebo.
干预措施: Urethroplasty (Procedure)
Placebo
Control group, children with severe hypospadias treated with Placebo.
干预措施: Wrist X ray (Radiation)
Placebo
Control group, children with severe hypospadias treated with Placebo.
干预措施: Blood test (Procedure)
结局指标
主要结局
Number of patient with postoperative urethral fistula and dehiscence
时间窗: 1 year
次要结局
- Clinical tolerance of the treatment(14 months)
- Bone age evaluation(14 monthes)
- Re-intervention related to wound healing(1 year)
- post-surgical complications(1 year)
- Re-intervention not related to wound healing(1 year)
- Hormone measurement(2 months)