Chronic Idiopathic Constipation, Functional Constipation
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGBotulinum Toxin
Injection of Botulinum toxin under general anesthesia. Four injections will be given into the anal sphincter into the four quadrants in one session.
PROCEDUREAnal Myectomy
Longitudinal anal myectomy will be performed under general anesthesia as a day case.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children with Idiopathic constipation
Exclusion criteria
* Hirschsprung's disease or Anorectal malformations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of insufficient Rome III Diagnostic criteria (0-1 criterion) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Rome III Diagnostic criteria score | 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 improving Chronic idiopathic constipation is denoted by giving each case a 6-point score system based on Chronic idiopathic constipation diagnostic criteria. Improvement is denoted by decrease in diagnostic criteria score after receiving corresponding arm of the study. The decrease is assessed, analyzed and compared between the two groups. |
Countries
Egypt
Outcome results
None listed