Condition category
Cancer
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
03/10/2012
Prospective/Retrospective
Retrospectively 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

Prof Greg Rubin

ORCID ID

Contact details

School of Science
University of Sunderland
Benedict Building
St George’s Way
Sunderland
SR2 7BW
United Kingdom
+44 (0)191 515 3831

Additional identifiers

EudraCT 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/03/1997

Overall trial end date

30/06/1999

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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

http://www.doh.gov.uk

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10622694

Publication citations

  1. Results

    Dougall A, Russell A, Rubin G, Ling J, Rethinking patient satisfaction: patient experiences of an open access flexible sigmoidoscopy service., Soc Sci Med, 2000, 50, 1, 53-62.

Additional files

Editorial Notes