Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation
NCT ID: NCT02361749
Last Updated: 2018-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2014-09-30
2018-12-31
Brief Summary
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Detailed Description
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In this study, the investigators will compare the results of botulinum toxin injection versus surgical myectomy to treat functional/idiopathic constipation in children.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Myectomy group
Subjects will undergo anal myectomy for their anal sphincter.
Anal Myectomy
Longitudinal anal myectomy will be performed under general anesthesia as a day case.
Botox Group
Subjects will undergo Botulinum toxin injection into their anal sphincter.
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.
Interventions
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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.
Anal Myectomy
Longitudinal anal myectomy will be performed under general anesthesia as a day case.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Years
12 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mahmoud Elfiky, MD
Lecturer of Pediatric Surgery
Principal Investigators
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Mohamed Seoudi
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Cairo University Pediatric Hospital
Cairo, , Egypt
Countries
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References
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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.
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.
Other Identifiers
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PACTR201408000857349
Identifier Type: OTHER
Identifier Source: secondary_id
CAIUNIPEDSURG-CR2
Identifier Type: -
Identifier Source: org_study_id
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