Contact information
Type
Scientific
Primary contact
Prof John Bond
ORCID ID
Contact details
Centre for Health Services Research
University of Newcastle upon Tyne
21 Claremont Place
Newcastle upon Tyne
NE2 4AA
United Kingdom
+44 (0)191 222 6777
john.bond@newcastle.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 98/32/99
Study information
Scientific title
Acronym
STOOL
Study hypothesis
1. To investigate the clinical and cost effectiveness of bulk forming, stimulant and osmotic laxatives prescribed by primary care to ambulant older people living at home.
2. To investigate the clinical and cost effectiveness of prescribing an additional second type of laxative agent in the treatment of patients whose constipation is not resolved by a single agent.
3. To describe the adherence by patients to treatment protocols.
Ethics approval
Not provided at time of registration.
Study design
Pragmatic factorial randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Constipation
Intervention
Different forms of stepped pharmacological treatment of constipation with economic evaluation. An add-on qualitative study of the meaning and experience of constipation to older people and the views of general practitioners.
Added as of 25/08/2009: the trial was closed after recruiting 19 participants due to problem with recruitment.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The primary clinical outcome is the reported number of bowel movements per week at the end of each step (6 and 10 weeks after randomisation) and at six months follow-up.
Secondary outcome measures
Secondary clinical outcomes include the presence/absence of the other Rome criteria for constipation; adverse effects of treatment (although some of these may also be symptoms of constipation); and relapse rates. In addition to the measurement of these clinical outcomes, patient satisfaction and the impact of the treatment on costs and quality of life will be assessed
Overall trial start date
01/10/2002
Overall trial end date
30/04/2006
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
People aged 55 or over with chronic constipation living in private households.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
19
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/10/2002
Recruitment end date
30/04/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Health Services Research
Newcastle upon Tyne
NE2 4AA
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18462572
Publication citations
-
Results
Mihaylov S, Stark C, McColl E, Steen N, Vanoli A, Rubin G, Curless R, Barton R, Bond J, Stepped treatment of older adults on laxatives. The STOOL trial., Health Technol Assess, 2008, 12, 13, iii-iv, ix-139.