Evaluation of guidelines for open access flexible sigmoidoscopy

ISRCTN	ISRCTN53354739
DOI	https://doi.org/10.1186/ISRCTN53354739
Protocol serial number	PSI B-10
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

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

School of Science
University of Sunderland
Benedict Building
St Georges Way
Sunderland
SR2 7BW
United Kingdom

Phone	+44 (0)191 515 3831

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/1999

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
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

United Kingdom
England

Study participating centre

School of Science

Sunderland
SR2 7BW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes