- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02361749
Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation
Comparative Study Between Botulinum Toxin Injection and Myectomy in Treatment of Idiopathic Constipation in Children
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Cairo, Egypt, 11432
- Cairo University Pediatric Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children with Idiopathic constipation
Exclusion Criteria:
- Hirschsprung's disease or Anorectal malformations
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Myectomy group
Subjects will undergo anal myectomy for their anal sphincter.
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Longitudinal anal myectomy will be performed under general anesthesia as a day case.
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Active Comparator: Botox Group
Subjects will undergo Botulinum toxin injection into their anal sphincter.
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Injection of Botulinum toxin under general anesthesia.
Four injections will be given into the anal sphincter into the four quadrants in one session.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absence of insufficient Rome III Diagnostic criteria (0-1 criterion)
Time Frame: 2 years
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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:
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in Rome III Diagnostic criteria score
Time Frame: 2 years
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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:
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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Seoudi, Cairo University
Publications and helpful links
General Publications
- Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.
- Keshtgar AS, Ward HC, Sanei A, Clayden GS. Botulinum toxin, a new treatment modality for chronic idiopathic constipation in children: long-term follow-up of a double-blind randomized trial. J Pediatr Surg. 2007 Apr;42(4):672-80. doi: 10.1016/j.jpedsurg.2006.12.045.
- Irani K, Rodriguez L, Doody DP, Goldstein AM. Botulinum toxin for the treatment of chronic constipation in children with internal anal sphincter dysfunction. Pediatr Surg Int. 2008 Jul;24(7):779-83. doi: 10.1007/s00383-008-2171-3. Epub 2008 Apr 29.
- Hata Y, Sasaki F, Uchino J. Sphincteromyectomy and sphincteroplasty in chronic constipation with megarectum. J Pediatr Surg. 1988 Feb;23(2):141-2. doi: 10.1016/s0022-3468(88)80143-x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAIUNIPEDSURG-CR2
- PACTR201408000857349 (Other Identifier: PACTR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Ferring PharmaceuticalsWithdrawn
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