This trial is active, not recruiting.

Conditions chronic idiopathic constipation, functional constipation
Treatments botulinum toxin, anal myectomy
Phase phase 4
Sponsor Cairo University
Start date September 2014
End date December 2016
Trial size 40 participants
Trial identifier NCT02361749, CAIUNIPEDSURG-CR2, PACTR201408000857349


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Subjects will undergo anal myectomy for their anal sphincter.
anal myectomy
Longitudinal anal myectomy will be performed under general anesthesia as a day case.
(Active Comparator)
Subjects will undergo Botulinum toxin injection into their anal sphincter.
botulinum toxin Botox
Injection of Botulinum toxin under general anesthesia. Four injections will be given into the anal sphincter into the four quadrants in one session.

Primary Outcomes

Absence of insufficient Rome III Diagnostic criteria (0-1 criterion)
time frame: 2 years

Secondary Outcomes

Decrease in Rome III Diagnostic criteria score
time frame: 2 years

Eligibility Criteria

Male or female participants from 2 years up to 12 years old.

Inclusion Criteria: - Children with Idiopathic constipation Exclusion Criteria: - Hirschsprung's disease or Anorectal malformations

Additional Information

Official title Comparative Study Between Botulinum Toxin Injection and Myectomy in Treatment of Idiopathic Constipation in Children
Principal investigator Mohamed Seoudi
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Cairo University.