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ISRCTN
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ISRCTN58539902
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ClinicalTrials.gov identifier
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Public title
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Randomised study comparing the effects of lateral anal sphincterotomy, glyceryl trinitrate and botulinium toxin in the management of chronic anal fissures
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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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N0051116137
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Study hypothesis
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To determine whether botulinium toxin is clinically and financially an effective out patient alternative to Glyceryl Trinitrate and lateral anal sphincterotomy treatment of chronic anal fissures.
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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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Double blind randomised 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: Chronic annal fissure
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Participants - inclusion criteria
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120 males and females aged 18-65
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/04/2002
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Anticipated end date
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31/03/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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120
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Interventions
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Double blind randomised trial, incorporating clinical and laboratory examinations prior to application of the drug at one week and one, two, three and six months post application.
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Primary outcome measure(s)
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Not provided at time of registration
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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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Brighton and Sussex University Hospitals NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Mr
Paul
Farrands
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Address
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Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
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City/town
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Brighton
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Zip/Postcode
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BN2 5BE
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Country
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United Kingdom
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Tel
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+44 01273 696955 X 4647
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Fax
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+44
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Email
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paul.farrands@bsuh.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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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
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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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28/09/2007
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Last edited
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21/05/2008
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Date ISRCTN assigned
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28/09/2007
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