Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation

Phase 4

• Conditions: Functional Constipation; Chronic Idiopathic Constipation
• Interventions: Procedure: Anal Myectomy; Drug: Botulinum Toxin

• Registration Number: NCT02361749
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-02-08
• Study First Posted: 2015-02-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-27
• Last Update Posted: 2018-01-30
• Primary Completion: 2018-08
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Children with Idiopathic constipation

Exclusion Criteria

• Hirschsprung's disease or Anorectal malformations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Myectomy group	Anal Myectomy	Subjects will undergo anal myectomy for their anal sphincter.
Botox Group	Botulinum Toxin	Subjects will undergo Botulinum toxin injection into their anal sphincter.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cairo University Pediatric Hospital; 🇪🇬 Cairo, Egypt