跳至主要内容
临床试验/NCT02212054
NCT02212054招募中不适用

A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Children With Hirschsprung Allied Disease

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
the change of defecation frequency

研究概览

简要总结

The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease

详细描述

The present study was designed to compare the efficacy of conservative treatment,such as anal dilatation, colonic lavage and so on, to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease

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
None

入排标准

年龄范围
1 Year 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • hard or firm stools for twice or less per week
  • a predicting score of less than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis,
  • 28(5): p. 689-96

排除标准

  • functional constipation
  • a predicting score of more than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis,
  • 28(5): p. 689-96

结局指标

主要结局

the change of defecation frequency

时间窗: 6~12 months

the changes of defecation frequency at 6\~12 months after treatment

次要结局

  • complications(6~12 months)
  • stool pattern(6~12 months)
  • controlling stool ability(6~12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Feng Jiexiong

Chief of pediatric surgery department

Tongji Hospital

研究点 (1)

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