Computed tomography (CT) colonography, colonoscopy, or barium enema for diagnosis of colorectal cancer in older symptomatic patients

ISRCTN	ISRCTN95152621
DOI	https://doi.org/10.1186/ISRCTN95152621
Secondary identifying numbers	HTA 02/02/01

Submission date: 07/07/2004
Registration date: 07/07/2004
Last edited: 01/03/2022

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

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-a-new-test-to-help-diagnose-older-people-with-symptoms-of-bowel-cancer

Contact information

Dr Steve Halligan
Scientific

Department of Specialist Radiology
University College Hospital
Level 2 Podium
235 Euston Road
London
NW1 2BU
United Kingdom

Phone	+44 (0)20 7380 9010
Email	s.halligan@ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Computed tomography (CT) colonography, colonoscopy, or barium enema for diagnosis of colorectal cancer in older symptomatic patients
Study acronym	SIGGAR1
Study hypothesis	CT colonography (CTC) is a new health technology for examination of the large bowel that is disseminating at a rapid rate, based on results from small trials that suggest that it is as sensitive as colonoscopy for detecting bowel cancer and large polyps but safer and more acceptable to patients. Many advocate using CTC to screen for bowel cancer (notably in the USA where the technique has received considerable media attention) but in the UK it is more likely that it will find a role for detecting bowel cancer in patients who have symptoms. The symptoms of bowel cancer are very non-specific (e.g. abdominal pain, rectal bleeding, change in bowel habit, etc) and most people who have these symptoms won't have bowel cancer. However, they may still need to see a doctor and undergo a bowel examination in order to exclude the disease. The standard tests for looking at the large bowel are colonoscopy and barium enema. Colonoscopy involves the passage of a thin endoscope around the large bowel with a camera at its tip, looking for cancer. It is expensive, difficult to perform, and occasionally dangerous, especially in older patients. The alternative is barium enema, where the bowel is filled with liquid and x-rays then taken. A barium enema is safer, cheaper, and easier to perform than a colonoscopy but misses more cancer. CT colonography is a new test that examines the large bowel using a CT scanning machine. Intriguingly, It also affords the opportunity to look at the organs outside the large bowel, and might thus be able to determine if the patient's symptoms are coming from elsewhere. The evidence to date suggests that CTC is as sensitive as colonoscopy for detecting cancer but is also safer. It might therefore have an important role in the NHS for rapid, accurate, acceptable, safe, and cost-effective investigation of symptomatic patients. This trial compares CTC with colonoscopy and barium enema in two parallel, prospective multicentre randomised trials (randomised 2 to 1 in favour of the standard test), with choice of the standard test depending on local factors such as availability and expertise. The detection or exclusion of significant large bowel cancer/polyps will be determined for each of the three tests, including the number and nature of any additional tests required to confidently exclude bowel cancer and the incidence, nature, and significance of incidental disease outside the large bowel detected by CTC. The frequency and nature of procedure-related adverse events will be recorded and the psychological effects of each test will be measured using validated questionnaires. Patient-specific records of costs and outcomes including the influence of having follow-up tests and multiple investigations will be obtained and models developed to compare management plans with outcome cost. We will also use the data collected to populate models that summarise the health effects and costs of these alternative diagnostic approaches in patients of differing ages, risks, and preferences. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/020201 Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0016/50623/PRO-02-02-01.pdf Added 25/02/2022: In conjunction with the SIGGAR trial comparing methods of whole bowel examination, it became apparent that further investigation was necessary to find a reliable way of distinguishing between patients who need only flexible sigmoidoscopy (FS) examination of the lower bowel and those who require more extensive investigation of the whole bowel. A previous study of 16,000 patients with symptoms of bowel cancer found that 86% of cancers were found in the distal colon (and were therefore possible to detect at FS), but this proportion rose to 95% in patients whose symptoms did not include anaemia or an abdominal mass that the doctor could feel on examination. Therefore, it seemed likely that patients without these symptoms could be adequately investigated by FS, while any patients with anaemia or an abdominal mass would require investigation of the whole bowel. These results were encouraging but were based on data from only one hospital, so it was important to confirm them more widely; this was the focus of the SOCCER study (long title: Is whole colon investigation by colonoscopy, CT colonography or barium enema necessary for all patients with colorectal cancer symptoms, and for which patients would flexible sigmoidoscopy suffice?). The research team was in an ideal position to do this because they already had details of the patients approached for the SIGGAR trial, which recruited from 21 NHS hospitals around the country. All of these patients eligible for the SIGGAR trial were referred to hospital with symptoms suggestive of bowel cancer. The SOCCER study collected blood test results to identify anaemia. Patients' notes and discharge letters were checked for any reference to an abdominal mass. Finally, the SOCCER study collected cancer diagnoses and deaths and confirmed whether the cancer was in the upper or lower part of the bowel. The SOCCER study consisted of patients who took part in the SIGGAR trial as well as those who were registered as eligible for the SIGGAR trial but ultimately did not take part in that trial.
Ethics approval(s)	Not provided at time of registration
Condition	Colon cancer
Intervention	CT colonography, barium enema, colonoscopy
Intervention type	Procedure/Surgery
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/02/2004
Overall study end date	01/11/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	5,025
Total final enrolment	7375
Participant inclusion criteria	Individuals with symptoms suggestive of colorectal cancer, aged 55 years or older.
Participant exclusion criteria	Not provided at time of registration
Recruitment start date	01/02/2004
Recruitment end date	01/11/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College Hospital

London
NW1 2BU
United Kingdom

Sponsor information

Imperial College London (UK)
Government

South Kensington Campus
London
SW7 2AZ
United Kingdom

Website	http://www3.imperial.ac.uk
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to agreements in place with data providers

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results	SIGGAR trial			No	Yes
Results article	SIGGAR trial	27/10/2007		Yes	No
Results article	SIGGAR trial	01/10/2011		Yes	No
Results article	SIGGAR trial	01/06/2012		Yes	No
Results article	SIGGAR trial	06/04/2013		Yes	No
Results article	SIGGAR trial	06/04/2013		Yes	No
Results article	SIGGAR trial	01/07/2015		Yes	No
Results article	SIGGAR trial	01/07/2015		Yes	No
Protocol (other)	SOCCER sub-study	25/02/2013	25/02/2022	No	No
Results article	Economic evaluation alongside the SIGGAR trial	26/10/2014	25/02/2022	Yes	No
Results article	SIGGAR trial	29/09/2008	25/02/2022	Yes	No
Results article	SOCCER sub-study	01/11/2017	25/02/2022	Yes	No
Results article	SOCCER sub-study	19/12/2018	25/02/2022	Yes	No
Plain English results	SOCCER sub-study	01/11/2017	01/03/2022	No	Yes

Editorial Notes

01/03/2022: Publication reference, total final enrolment and IPD sharing statement added.
25/02/2022: The study hypothesis was updated. Publication references added.
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
04/05/2016: Publication reference added.
15/01/2009: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/01/2009 to 01/11/2007 (end of recruitment).
2. The target number of participants was added.
25/01/2008: The overall trial start and end dates were changed from 01/10/2003 and 31/03/2007 to 01/02/2004 and 31/01/2009, respectively.