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临床试验/NCT02960529
NCT02960529Unknown不适用

A Comparative Study on Trans-umbilical Single-port Laparoscopic Extra-peritoneal Approach Versus Conventional Repair for Inguinal Hernia in Children

zebing Zheng1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
conversion to intraabdominal high ligation of inguinal hernia

研究概览

简要总结

Inguinal hernia is a common disease in children. Treatment of this disease by laparoscopic high ligation of the hernia sac has been accepted by domestic and foreign scholars. Since laparoscopic inguinal hernia was introduced in 1990,it has now become the most commonly performed hernia repair in children. The conventional approach this is done with2small trocars to 1trocar . however the wound complications of infection and pain and the recurrent rate have not been resolved. The aim of the study was to described a new way of extra-peritoneal high ligation of hernia sac. This method combines the single-port laparoscopic could eliminated rate of wound complications and recurrence in inguinal hernia repair in children. The investigators hoped that this study will prove that the extra-peritoneal single-port laparoscopic repair is at least a s effective and efficient as the conventional technique in the cure of inguinal hernia and may results in lower recurrence and reduce incidence of wound complications.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Months 至 13 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • unilateral inguinal herina age between 6 months and 13 years no history of abdominal or inguinal operations of male patients ,only those with completely descended testes were included

排除标准

  • the bilateral heina the recurrence herina

结局指标

主要结局

conversion to intraabdominal high ligation of inguinal hernia

时间窗: during operation

this study is to determine whether extra-peritoneal single-port laparoscopic repair for inguinal hernia in children is superior to conventional repair approaches.

次要结局

  • post operative pain scores(preop, day one and day 7 postop)
  • recurrence of inguinal herina(1 year)
  • length of hospital time(day procedure or overnight stay)
  • operating time(during operation)
  • post-operation complications including wound infection,stitch abscess, spermatic cord injuries,testicular atrophy.(6 weeks)

研究者

发起方
zebing Zheng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

zebing Zheng

Affiliated hospital of Zunyi medical college

Zunyi Medical College

研究点 (1)

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