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Design of a multicentre randomized trial to evaluate CT colonography versus colonoscopy or barium enema for the diagnosis of colonic cancer in older symptomatic patients: The SIGGAR study.

Title: Design of a multicentre randomized trial to evaluate CT colonography versus colonoscopy or barium enema for the diagnosis of colonic cancer in older symptomatic patients: The SIGGAR study.
Authors: Halligan, S
Lilford, RJ
Wardle, J
Morton, D
Rogers, P
Wooldrage, K
Edwards, R
Kanani, R
Shah, U
Atkin, W
Item Type: Journal Article
Abstract: ABSTRACT: Background and Aims: The standard whole-colon tests used to investigate patients with symptoms of colorectal cancer are barium enema and colonoscopy. Colonoscopy is the reference test but is technically difficult, resource intensive, and associated with adverse events, especially in the elderly. Barium enema is safer but has reduced sensitivity for cancer. CT colonography ("virtual colonoscopy") is a newer alternative that may combine high sensitivity for cancer with safety and patient acceptability. The SIGGAR trial aims to determine the diagnostic efficacy, acceptability, and economic costs associated with this new technology. METHODS: The SIGGAR trial is a multi-centre randomised comparison of CT colonography versus standard investigation (barium enema or colonoscopy), the latter determined by individual clinician preference. Diagnostic efficacy for colorectal cancer and colonic polyps measuring 1cm or larger will be determined, as will the physical and psychological morbidity associated with each diagnostic test, the latter via questionnaires developed from qualitative interviews. The economic costs of making or excluding a diagnosis will be determined for each diagnostic test and information from the trial and other data from the literature will be used to populate models framed to summarise the health effects and costs of alternative approaches to detection of significant colonic neoplasia in patients of different ages, prior risks and preferences. This analysis will focus particularly on the frequency, clinical relevance, costs, and psychological and physical morbidity associated with detection of extracolonic lesions by CT colonography. RESULTS: Recruitment commenced in March 2004 and at the time of writing (July 2007) 5025 patients have been randomised. A lower than expected prevalence of end-points in the barium enema sub-trial has caused an increase in sample size. In addition to the study protocol, we describe our approach to recruitment, notably the benefits of extensive piloting, the use of a sham-randomisation procedure, which was employed to determine whether centres interested in participating were likely to be effective in practice, and the provision of funding for dedicated sessions for a research nurse at each centre to devote specifically to this trial.
Issue Date: 27-Oct-2007
URI: http://hdl.handle.net/10044/1/53355
DOI: https://dx.doi.org/10.1186/1745-6215-8-32
ISSN: 1745-6215
Journal / Book Title: Trials
Volume: 8
Issue: 1
Copyright Statement: © 2007 Halligan et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons. org/licenses/by/2.0 ), which permits unrestricted use, distribution, and reproduction in any medium, provided the orig inal work is properly cited.
Sponsor/Funder: Department of Health
Funder's Grant Number: 02/02/01
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
1102 Cardiovascular Medicine And Haematology
1103 Clinical Sciences
Cardiovascular System & Hematology
General & Internal Medicine
Conference Place: United Kingdom
Appears in Collections:Department of Surgery and Cancer