Comparative Study Between Botulinum Toxin Injection and Myectomy in Treatment of Idiopathic Constipation in Children
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Absence of insufficient Rome III Diagnostic criteria (0-1 criterion)
研究概览
简要总结
Chronic idiopathic constipation is most common cause of Constipation in childhood with numerous cases in Egypt. Numerous conservative measures were tried but many fail. Surgical options include Longitudinal Myectomy of the muscle or injection of Botulinum toxin. Objectives: Comparative study between Botulinum toxin injection and Myectomy in treatment of Idiopathic Constipation
详细描述
Functional constipation (chronic idiopathic constipation) is most common cause of constipation in pediatric age group. Many cases try conservative treatment but fail to respond. These cases are treated by surgical longitudinal myectomy of the anal sphincter. Now, there have been many trials of trying injection of botulinum toxin to relax the sphincter as a treatment of functional/idiopathic constipation.
In this study, the investigators will compare the results of botulinum toxin injection versus surgical myectomy to treat functional/idiopathic constipation in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with Idiopathic constipation
排除标准
- •Hirschsprung's disease or Anorectal malformations
研究组 & 干预措施
Myectomy group
Subjects will undergo anal myectomy for their anal sphincter.
干预措施: Anal Myectomy (Procedure)
Botox Group
Subjects will undergo Botulinum toxin injection into their anal sphincter.
干预措施: Botulinum Toxin (Drug)
结局指标
主要结局
Absence of insufficient Rome III Diagnostic criteria (0-1 criterion)
时间窗: 2 years
Rome III Diagnostic criteria for chronic idiopathic constipation include two or more of the following in a child with a developmental age of at least 4 years: 1. Two or fewer defecations in the toilet per week 2. At least one episode of fecal incontinence per week 3. History of retentive posturing or excessive volitional stool retention 4. History of painful or hard bowel movements 5. Presence of a large fecal mass in the rectum 6. History of large diameter stools which may obstruct the toilet Outcome measure for Curing Chronic idiopathic constipation is denoted by absence of insufficient criteria (0-1 criterion) to diagnose Chronic idiopathic constipation after receiving corresponding arm of the study.
次要结局
- Decrease in Rome III Diagnostic criteria score(2 years)
研究者
Mahmoud Elfiky, MD
Lecturer of Pediatric Surgery
Cairo University