Condition category
Digestive System
Date applied
01/03/2001
Date assigned
01/03/2001
Last edited
25/11/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.action.org.uk/

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

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15486330

Publication citations

  1. 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.

Additional files

Editorial Notes