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ISRCTN
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ISRCTN87167979
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DOI
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10.1186/ISRCTN87167979
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Treatment of bowel dysfunction in stroke patients: a randomised controlled trial
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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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AP0763
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Study hypothesis
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To evaluate treatment of constipation and faecal incontinence in stroke survivors
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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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Bowel dysfunction
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Participants - inclusion criteria
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1. Symptoms of faecal incontinence, constipation, and/or rectal outlet delay
2. Within 2 years of acute stroke
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Participants - exclusion criteria
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Reporting acute diarrhoea or colonic disease other than diverticular disease
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Anticipated start date
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01/01/2003
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Anticipated end date
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01/01/2004
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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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146
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Interventions
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Stroke patients within 2 years of their initial acute cerebrovascular accident (CVA) will be screened by a 9-item bowel symptom questionnaire and cognitive assessment. Eligible patients will be randomised to intervention or control groups:
1. The intervention group will undergo a single clinical assessment including a symptom history, rectal examination, and where relevant, an abdominal radiograph leading to a treatment programme consisting of appropriate bowel medications, sphincter exercises where relevant and education with the use of a self-care booklet on all issues relevant to bowel problems in stroke
2. The control group will receive usual care from their hospital or General Practitioner
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Primary outcome measure(s)
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Percentage of bowel movements (BMs) per week graded as "normal" by participants in a prospective 1-week stool diary.
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Secondary outcome measure(s)
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1. Percentage of BM graded as normal by the patient and number of faecal incontinence (FI) episodes, measured by postal prospective 7-day stool diary at 1, 3, 6, and 12 months
2. Bowel-related symptoms
3. Visual analogue scores for severity rating
4. Quality of life (bowel-related and 12-item Short Form Health Survey [SF-12])
5. Self-reported treatment
6. Resource use
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Sources of funding
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Action Medical Research (UK)
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Trial website
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Publications
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2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15486330
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Contact name
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Dr
Danielle
Harari
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Address
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Elderly Care Unit
9th Floor North Wing
St.Thomas' Hospital
Lambeth Palace Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Tel
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+44 (0)20 7922 8039
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Fax
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+44 (0)20 7928 2339
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Email
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danielle.harari@kcl.ac.uk
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Sponsor
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Action Medical Research (UK)
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Address
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Vincent House
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City/town
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Horsham West Sussex
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Zip/Postcode
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RH12 2DP
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Country
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United Kingdom
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Sponsor website:
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http://www.action.org.uk/
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Date applied
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01/03/2001
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Last edited
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25/11/2010
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Date ISRCTN assigned
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01/03/2001
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