NCT01985646已完成早期 1 期
A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Normal and Short-segment Hirschsprung Disease for Infants
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- the change of defecation frequence
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 infants with short or normal-segment Hirschsprung 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
- — 至 3 Months（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
- •Age were from newborn to 3 months
- •Histochemical acetylcholinesterase reaction (AChE) in rectal mucosa was positive
- •The narrowed distal bowel on barium enema was characterized as normal or short-segment Hirschsprung disease with a 24h barium retention
排除标准
- •Children >3months of age
- •Patients presented severe inflammation or malnutrition, unconsciousness, and symptoms of a ruptured hollow viscus
- •Barium enema showed long-segment or total colonic aganglionic bowel
研究组 & 干预措施
surgery treatment
Experimental
one stage pull through left-colectomy
干预措施: surgery treatment (Procedure)
conservative treatment
Experimental
anal dilation, colonic lavage, oral probiotic
干预措施: anal dilation (Behavioral)
conservative treatment
Experimental
anal dilation, colonic lavage, oral probiotic
干预措施: colonic lavage (Behavioral)
conservative treatment
Experimental
anal dilation, colonic lavage, oral probiotic
干预措施: oral probiotic (Drug)
结局指标
主要结局
the change of defecation frequence
时间窗: 6~12 months
the changes of defecation frequence at 6\~12 months after treatment
次要结局
- stool pattern(6~12 months)
- controlling defecation ability(6~12 months)
- complications(6~12 months)
研究者
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