A Phase 4 interventional study of Botulinum Toxin and Anal Myectomy in Chronic Idiopathic Constipation and Functional Constipation, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2018-01-30.
Sponsored by Cairo University · Phase 4, Interventional, and Treatment
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
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Subjects will undergo anal myectomy for their anal sphincter.
Procedure: Anal Myectomy
Subjects will undergo Botulinum toxin injection into their anal sphincter.
Drug: Botulinum Toxin
Injection of Botulinum toxin under general anesthesia. Four injections will be given into the anal sphincter into the four quadrants in one session.
Also known as: Botox
Longitudinal anal myectomy will be performed under general anesthesia as a day case.
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: 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.
Time frame: 2 years
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: 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.
Time frame: 2 years
Plan to share: Yes — WOFAPS 2016
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Cairo University