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Randomised controlled trial of injection of botulinum toxin into the internal anal sphincter versus control in treatment of chronic idiopathic constipation in children

Randomised controlled trial of injection of botulinum toxin into the internal anal sphincter versus control in treatment of chronic idiopathic constipation in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24521269
Enrollment
80
Registered
2005-09-30
Start date
2003-10-08
Completion date
Unknown
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System: Constipation Digestive System Constipation

Interventions

A randomized-controlled trial of botulinum toxin injection versus control in children with chronic idiopathic constipation. The children are randomly allocated by surgeons into two treatment groups af

Sponsors

Department of Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 80 children with idiopathic chronic constipation referred for anorectal manometry and inpatient bowel management programme.

Exclusion criteria

Exclusion criteria: 1. Patients younger than 3 years old or older than 16 years 2. Severe learning difficulty 3. Evidence of Hirschsprungs disease on anorectal manometry 4. Previous anal surgery

Design outcomes

Primary

MeasureTime frame
Improvement in patients symptom severity score determined by parents completed questionnaire.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026