跳至主要内容
临床试验/NCT01477593
NCT01477593已完成4 期

Circumcision With a Novel Disposable Device in Chinese Children: a Hospital-based Randomized Controlled Trail

Feng Pan0 个研究点目标入组 120 人开始时间: 2009年7月1日最近更新:
适应症

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

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

发起方
Feng Pan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Feng Pan

Clinical Attending Doctor

Nanjing Medical University

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