Treatment of bowel dysfunction in stroke patients: a randomised controlled trial

ISRCTN	ISRCTN87167979
DOI	https://doi.org/10.1186/ISRCTN87167979
Secondary identifying numbers	AP0763

Submission date: 01/03/2001
Registration date: 01/03/2001
Last edited: 25/11/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Danielle Harari
Scientific

Elderly Care Unit
9th Floor North Wing
St.Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Phone	+44 (0)20 7922 8039
Email	danielle.harari@kcl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	To evaluate treatment of constipation and faecal incontinence in stroke survivors
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2003
Completion date	01/01/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	146
Key inclusion criteria	1. Symptoms of faecal incontinence, constipation, and/or rectal outlet delay 2. Within 2 years of acute stroke
Key exclusion criteria	Reporting acute diarrhoea or colonic disease other than diverticular disease
Date of first enrolment	01/01/2003
Date of final enrolment	01/01/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Elderly Care Unit

London
SE1 7EH
United Kingdom

Sponsor information

Action Medical Research (UK)
Charity

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Website	http://www.action.org.uk/
"ROR"	https://ror.org/01wcqa315

Funders

Funder type

Charity

Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): actionmedres, action medical research for children, AMR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2004		Yes	No