Evaluation of guidelines for open access flexible sigmoidoscopy
| ISRCTN | ISRCTN53354739 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53354739 |
| Secondary identifying numbers | PSI B-10 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 03/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Greg Rubin
Scientific
Scientific
School of Science
University of Sunderland
Benedict Building
St Georges Way
Sunderland
SR2 7BW
United Kingdom
| Phone | +44 (0)191 515 3831 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 30/06/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/03/1997 |
| Date of final enrolment | 30/06/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Science
Sunderland
SR2 7BW
United Kingdom
SR2 7BW
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
No information available
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 | 01/01/2000 | Yes | No |
