Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation

Functional Constipation Clinical Trial

Official title:

Comparative Study Between Botulinum Toxin Injection and Myectomy in Treatment of Idiopathic Constipation in Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02361749
• Other study ID #: CAIUNIPEDSURG-CR2
• Secondary ID: PACTR20140800085
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 9, 2015
• Last updated: January 27, 2018
• Start date: September 2014
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children with Idiopathic constipation

Exclusion Criteria:

• Hirschsprung's disease or Anorectal malformations

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation
• Functional Constipation

Intervention

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.

Locations

Country	Name	City	State
Egypt	Cairo University Pediatric Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. Review. — View Citation

Hata Y, Sasaki F, Uchino J. Sphincteromyectomy and sphincteroplasty in chronic constipation with megarectum. J Pediatr Surg. 1988 Feb;23(2):141-2. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	2 years