Contact information
Type
Scientific
Primary contact
Dr Danielle Harari
ORCID ID
Contact details
Elderly Care Unit
9th Floor North Wing
St.Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 (0)20 7922 8039
danielle.harari@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AP0763
Study information
Scientific title
Acronym
Study hypothesis
To evaluate treatment of constipation and faecal incontinence in stroke survivors
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Bowel dysfunction
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Percentage of bowel movements (BMs) per week graded as "normal" by participants in a prospective 1-week stool diary.
Secondary outcome measures
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
Overall trial start date
01/01/2003
Overall trial end date
01/01/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Symptoms of faecal incontinence, constipation, and/or rectal outlet delay
2. Within 2 years of acute stroke
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
146
Participant exclusion criteria
Reporting acute diarrhoea or colonic disease other than diverticular disease
Recruitment start date
01/01/2003
Recruitment end date
01/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Elderly Care Unit
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Action Medical Research (UK)
Sponsor details
Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Action Medical Research (UK)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15486330
Publication citations
-
Results
Harari D, Norton C, Lockwood L, Swift C, Treatment of constipation and fecal incontinence in stroke patients: randomized controlled trial., Stroke, 2004, 35, 11, 2549-2555, doi: 10.1161/01.STR.0000144684.46826.62.