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Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation

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ClinicalTrials.gov Identifier: NCT02361749
Recruitment Status : Active, not recruiting
First Posted : February 12, 2015
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Mahmoud Elfiky, MD, 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

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Constipation Functional Constipation Drug: Botulinum Toxin Procedure: Anal Myectomy Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study Between Botulinum Toxin Injection and Myectomy in Treatment of Idiopathic Constipation in Children
Study Start Date : September 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Active Comparator: Myectomy group
Subjects will undergo anal myectomy for their anal sphincter.
Procedure: Anal Myectomy
Longitudinal anal myectomy will be performed under general anesthesia as a day case.

Active Comparator: Botox Group
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.
Other Name: Botox




Primary Outcome Measures :
  1. Absence of insufficient Rome III Diagnostic criteria (0-1 criterion) [ Time Frame: 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 :
  1. Decrease in Rome III Diagnostic criteria score [ Time Frame: 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.




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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with Idiopathic constipation

Exclusion Criteria:

  • Hirschsprung's disease or Anorectal malformations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361749


Locations
Egypt
Cairo University Pediatric Hospital
Cairo, Egypt, 11432
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Mohamed Seoudi Cairo University

Publications:
Responsible Party: Mahmoud Elfiky, MD, Lecturer of Pediatric Surgery, Cairo University
ClinicalTrials.gov Identifier: NCT02361749     History of Changes
Other Study ID Numbers: CAIUNIPEDSURG-CR2
PACTR201408000857349 ( Other Identifier: PACTR )
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: WOFAPS 2016

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs