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ISRCTN
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ISRCTN24521269
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013146059
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Digestive System: Constipation
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Participants - inclusion criteria
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80 children with idiopathic chronic constipation referred for anorectal manometry and inpatient bowel management programme.
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Participants - exclusion criteria
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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
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Anticipated start date
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08/10/2003
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Anticipated end date
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01/05/2006
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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80
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Interventions
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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.
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Primary outcome measure(s)
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Improvement in patients symptom severity score determined by parents completed questionnaire.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust (UK) Own account NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Dr
Graham
Clayden
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Address
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Sherman Education Centre
F04 Thomas Guy House
Guy's Hospital
St Thomas Street
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 4593
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Email
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Graham.clayden@kcl.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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16/03/2010
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Date ISRCTN assigned
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30/09/2005
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