A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Children With Hirschsprung Allied Disease
试验速览
- 阶段
- 不适用
- 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
- 否
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
研究组 & 干预措施
conservative & operative treatment
anal dilation; colon lavage; probiotics
干预措施: conservative (Behavioral)
operative treatment
one stage pull- through radical colectomy
干预措施: operative (Procedure)
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
Feng Jiexiong
Chief of pediatric surgery department
Tongji Hospital
