Back to resultsBotulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation
Primary Purpose
Chronic Idiopathic Constipation, Functional Constipation
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Botulinum Toxin
Anal Myectomy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Idiopathic Constipation
Eligibility Criteria
Inclusion Criteria:
- Children with Idiopathic constipation
Exclusion Criteria:
- Hirschsprung's disease or Anorectal malformations
Sites / Locations
- Cairo University Pediatric Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Myectomy group
Botox Group
Arm Description
Subjects will undergo anal myectomy for their anal sphincter.
Subjects will undergo Botulinum toxin injection into their anal sphincter.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02361749
Brief Title
Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation
Official Title
Comparative Study Between Botulinum Toxin Injection and Myectomy in Treatment of Idiopathic Constipation in Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Constipation, Functional Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Myectomy group
Arm Type
Active Comparator
Arm Description
Subjects will undergo anal myectomy for their anal sphincter.
Arm Title
Botox Group
Arm Type
Active Comparator
Arm Description
Subjects will undergo Botulinum toxin injection into their anal sphincter.
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin
Other Intervention Name(s)
Botox
Intervention Description
Injection of Botulinum toxin under general anesthesia. Four injections will be given into the anal sphincter into the four quadrants in one session.
Intervention Type
Procedure
Intervention Name(s)
Anal Myectomy
Intervention Description
Longitudinal anal myectomy will be performed under general anesthesia as a day case.
Primary Outcome Measure Information:
Title
Absence of insufficient Rome III Diagnostic criteria (0-1 criterion)
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Decrease in Rome III Diagnostic criteria score
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with Idiopathic constipation
Exclusion Criteria:
Hirschsprung's disease or Anorectal malformations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Seoudi
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University Pediatric Hospital
City
Cairo
ZIP/Postal Code
11432
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
WOFAPS 2016
Citations:
PubMed Identifier
17448764
Citation
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.
Results Reference
background
PubMed Identifier
18443801
Citation
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.
Results Reference
background
PubMed Identifier
3343649
Citation
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.
Results Reference
background
PubMed Identifier
16678553
Citation
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.
Results Reference
background
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Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation
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