Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
PSI B-10
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the effect of guidelines on utilisation of an open access flexible sigmoidoscopy (OAFS) service and the subsequent clinical management of patients referred to it. To compare the management of patients referred to outpatient clinics or to OAFS in terms of process measures, clinical outcome and resource utilisation. To identify changes in referral case mix following introduction of guidelines for an OAFS.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Colorectal cancer
Intervention
1. Open access flexible sigmoidoscopy (OAFS) guidelines.
2. No guidelines.
Intervention type
Other
Primary outcome measure
1. Referrals/1000 population
2. Endoscopy findings
3. Final diagnoses
4. Time to diagnosis
5. Resource costs in primary and secondary care
6. Patient resource costs.
The introduction of the guideline had no significant effect on the selection of patients for investigation, but did influence patient management, both at the time of endoscopy and thereafter, the sum effect of which was reduced use of secondary care resources. GPs are selective in their use of an OAFS service for patients with rectal bleeding. The introduction of OAFS is cost effective and results in changes in case mix in referrals to specialist clinics. Non-malignant neoplasms were found more often in OAFS referrals, confirming the value of this service in evaluating low risk rectal bleeding.
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/03/1997
Overall study end date
30/06/1999
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients referred for open access flexible sigmoidoscopy and their referring practices.
2. Patients with symptomatic rectal bleeding referred for outpatient assessment prior to and during the study period.
3. < 18 years old
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/03/1997
Recruitment end date
30/06/1999
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
School of Science
Sunderland
SR2 7BW
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Primary and Secondary Care Interface National Research and Development Programme (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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2000 | Yes | No |