Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Study Between Botulinum Toxin Injection and Myectomy in Treatment of Idiopathic Constipation in Children

Conditions
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Chronic Idiopathic Constipation, Functional Constipation

Intervention / Treatment
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* Drug: Botulinum Toxin
* Procedure: Anal Myectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with Idiopathic constipation Exclusion Criteria: Hirschsprung's disease or Anorectal malformations

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Myectomy group<br>Subjects will undergo anal myectomy for their anal sphincter. | Procedure: Anal Myectomy<br>* Longitudinal anal myectomy will be performed under general anesthesia as a day case.<br>|
| Active Comparator: Botox Group<br>Subjects will undergo Botulinum toxin injection into their anal sphincter. | Drug: Botulinum Toxin<br>* Injection of Botulinum toxin under general anesthesia. Four injections will be given into the anal sphincter into the four quadrants in one session.<br>* Other names: Botox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of insufficient Rome III Diagnostic criteria (0-1 criterion) | 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: Two or fewer defecations in the toilet per week At least one episode of fecal incontinence per week History of retentive posturing or excessive volitional stool retention History of painful or hard bowel movements Presence of a large fecal mass in the rectum 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Rome III Diagnostic criteria score | 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: Two or fewer defecations in the toilet per week At least one episode of fecal incontinence per week History of retentive posturing or excessive volitional stool retention History of painful or hard bowel movements Presence of a large fecal mass in the rectum 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. | 2 years |