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

ISRCTN	ISRCTN24521269
DOI	https://doi.org/10.1186/ISRCTN24521269
Protocol serial number	N0013146059
Sponsor	Department of Health
Funder	Guy's and St. Thomas' NHS Foundation Trust (UK) Own account NHS R&D Support Funding

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 16/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Graham Clayden
Scientific

Sherman Education Centre
F04 Thomas Guy House
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom

Phone	+44 (0)20 7188 4593
Email	Graham.clayden@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled trial of injection of botulinum toxin into the internal anal sphincter versus control in treatment of chronic idiopathic constipation in children
Study objectives	To investigate the role of needle-free injection of botulinum toxin into external anal sphincter versus injection of the toxin into internal anal sphincter using ordinary needle versus control
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Digestive System: Constipation
Intervention	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 after anorectal manometry under ketamine anaesthetic: Group 1 = injection of botulinum toxin into the internal anal sphincter Group 2 = the control group who would have the benefits from the hospital admission to have anorectal studies, manual evacuation of stool if necessary, intensification of laxative treatment and toilet training but no botulinum toxin treatment.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Botulinum toxin
Primary outcome measure(s)	Improvement in patients symptom severity score determined by parents completed questionnaire.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/05/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	80
Key inclusion criteria	80 children with idiopathic chronic constipation referred for anorectal manometry and inpatient bowel management programme.
Key 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
Date of first enrolment	08/10/2003
Date of final enrolment	01/05/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Guy's Hospital

London
SE1 9RT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/04/2018: No publications found, study status unverified.
10/03/2016: No publications found, verifying study status with principal investigator