Stratifying risk of colorectal disease in symptomatic patients. V 1.0
Research type
Research Study
Full title
Stratifying risk of colorectal disease in order to direct the use of colonoscopy in symptomatic patients.
IRAS ID
181917
Contact name
Robert J C Steele
Contact email
Sponsor organisation
University of Dundee and NHS Tayside as Co-Sponsors
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Patients who have symptoms that could be attributable to bowel cancer, pre-cancerous polyps or inflammatory bowel disease (IBD) require investigation. Colonoscopy remains the gold standard, however, it is a precious resource and is both uncomfortable and potentially hazardous. Symptoms are common and non-specific, and an effective, simple means of determining which patients require investigation is urgently needed. Pilot studies indicate that estimation of faecal haemoglobin concentration (fHb) may act as an effective “rule-out“ test, but as many normal people have blood in the stool, unnecessary investigation would not be minimised using this parameter. In NHS Tayside, GPs wishing to refer a patient with colorectal symptoms for investigations are required to indicate symptoms and to request full blood count (FBC). Over a two-year period, a Faecal Immunochemical Test for haemoglobin will also be administered, with the test completed at home and returned in a purpose designed envelope to the Department of Biochemical Medicine where fHb will be estimated. Before undergoing investigation, all patients with fHb and FBC results available will be contacted to ask if they would be prepared to take part in the project. At the time of attendance for investigation, having given consent, BMI and waist circumference will be measured, and they will be asked to complete a short questionnaire on lifestyle, drug history, family history of bowel disease, and previous diagnosis of diabetes. All findings at investigation will be recorded on the routine endoscopy reporting system and subsequent histopathology results will be collected to determine the presence and nature of any colorectal disease. We propose to develop a simple risk score based on symptoms, fHb, FBC, age, gender, BMI, family history and lifestyle factors that will allow a rational, shared decision regarding the need for invasive investigation in people presenting to primary care with large bowel symptoms.
REC name
North of Scotland Research Ethics Committee 2
REC reference
15/NS/0101
Date of REC Opinion
12 Oct 2015
REC opinion
Further Information Favourable Opinion