Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Functional Constipation; Chronic Idiopathic Constipation

Treatments: Procedure: Anal Myectomy; Drug: Botulinum Toxin

Study type: Interventional

Funder types: Other

Identifiers

NCT02361749

CAIUNIPEDSURG-CR2

PACTR201408000857349 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children with Idiopathic constipation

Exclusion criteria

• Hirschsprung's disease or Anorectal malformations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Myectomy group

Active Comparator group

Description:

Subjects will undergo anal myectomy for their anal sphincter.

Treatment:

Procedure: Anal Myectomy

Botox Group

Active Comparator group

Description:

Subjects will undergo Botulinum toxin injection into their anal sphincter.

Treatment:

Drug: Botulinum Toxin