The Dilemma of Neonatal Circumcision in Egypt: A Comparative Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post circumcision bleeding
研究概览
简要总结
The study aims to compare wound healing, wound healing complications, cosmetic outcome, and level of parental satisfaction amongst four techniques of neonatal circumcision.
详细描述
Circumcision of a male child is the most common surgery performed globally. The prevalence of circumcision in this part of the world is over 80%, with the majority conducted in the neonatal period. The techniques of circumcision are diverse, and the method of circumcision may account for the differences in the outcome of the procedure.
Circumcision has complications like all surgical procedures. These typically include early complications such as leakage, hemorrhage, wound infection, pain, and swelling. However, more serious problems such as prolonged bleeding and amputation of the glans penis may also be encountered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male infants less than 3 months old.
- •Undergoing circumcision.
排除标准
- •Male infants more than 3 months old.
- •Infants with bleeding disorders.
- •Neonates with hypospadias, epispadias, micropenis, disorders of sex development (DSD)
- •Neonates with buried or webbed penis.
研究组 & 干预措施
Group 1
Patients will undergo circumcision by Plastibell (PB).
干预措施: Circumcision by Plastibell (Procedure)
Group 2
Patients will undergo circumcision by the Gomco (GM).
干预措施: Circumcision by Gomco (Procedure)
结局指标
主要结局
Post circumcision bleeding
时间窗: 2 hours postoperatively
All infants will be followed up for 2 hours for early detection and management of post circumcision bleeding.
次要结局
- Wound healing(7 days postoperatively)
- Parental satisfaction(4 weeks postoperatively)
研究者
Mohamed Ibrahim Ahmed Elmaadawy
Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University