Circumcision With a Novel Disposable Device in Chinese Children: a Hospital-based Randomized Controlled Trail
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- operation time
研究概览
简要总结
Circumcision, a removal of the foreskin, is performed commonly at any age in male worldwide. Globally over 25% of men are circumcised. In the Middle East, circumcision is even performed routinely in every male newborn. The benefits from it vastly outweigh the risks. Gradually, more and more Chinese male are willing to undergo it with themselves and their sons. But there are also some complications with circumcision, such as pain, edema, infection, and hemorrhage. Considering of that, physicians continually manage to improve their surgical methods and analgesic techniques.
In the study of Peng, a disposable minimally invasive circumcision anastomosis device named Shenghuan (China Wuhu Snnda Medical Treatment Application Technology Co. Ltd.) (ShD) was introduced to be applied in circumcision. And they concluded that method was quicker, safer and less pain than the conventional techniques of incision. In present study, we carry out a randomized controlled trail, using a different method as Peng introduced with this device in children's circumcision (Yan's), compared with the method as Peng used and the conventional technique in our hospital, and then observe the outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 11 Years(Child)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Children with phimosis or redundant prepuce
排除标准
- •Children with genital tract infection or deformity,
- •congenital diseases,
- •hematological diseases,
- •or other general diseases
结局指标
主要结局
operation time
时间窗: within operation
次要结局
- pain score(within operation)
研究者
Feng Pan
Clinical Attending Doctor
Nanjing Medical University
