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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Idiopathic Constipation
• Functional Constipation

Interventions

Type	Name	Description
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.
PROCEDURE	Anal Myectomy	Longitudinal anal myectomy will be performed under general anesthesia as a day case.

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-08-01
• Completion: 2018-12-01
• First posted: 2015-02-12
• Last updated: 2018-01-30

Locations

1 site across 1 country: Egypt