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ISRCTN
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ISRCTN40397527
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ClinicalTrials.gov identifier
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Public title
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A prospective randomised study comparing lateral internal sphincterotomy with anal dilatation in the treatment of 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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N0084144571
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Study hypothesis
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Are Lateral Internal Sphincterotomy (LIS) and Anal Dilatation for the treatment of anal fissures both acceptable procedures giving equal results?
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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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Prospective randomised study
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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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Surgery: Anal fissure
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Participants - inclusion criteria
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Not provided at time of registration
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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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02/06/2003
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Anticipated end date
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30/06/2004
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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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The aim of this study is to recruit 30 patients in each group to allow for patients lost to follow up and for patients who withdraw from the trial.
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Interventions
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Patients diagnosed as having anal fissure who have been advised to have surgery for the same, and who have agreed to such advice and fulfil the inclusion criteria will be invited to take part in the study until sample size is achieved.
Lateral internal sphincterotomy vs anal dilatation
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Primary outcome measure(s)
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1. The patient will be required to record all intake of Tramadol on the data collection sheet. The usage of as required medication would be used to calculate the difference in analgesic requirement between the two groups.
2. Anal incontinence will be assessed by the New St. Marks Score, extent of healing will be scored on a scale from 1 to 3, 1=no healing, 3=complete healing.
3. Pain scores on a numerical rating scale 0-10 will be collected from the patient as notes on day 1, day 5 and day 10.
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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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Northern Lincolnshire and Goole Hospitals NHS Trust (UK), 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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Mr
Muzaffar
Ahmad
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Address
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Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe General Hospital
Cliff Gardens
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City/town
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Scunthorpe
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Zip/Postcode
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DN15 7BH
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Country
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United Kingdom
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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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17/11/2010
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Date ISRCTN assigned
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30/09/2005
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