A trial looking at a new test to help diagnose older people with symptoms of bowel cancer (SIGGAR1)

This trial is comparing the new virtual colonoscopy test with standards tests used to help to diagnose bowel cancer.

Two of the standard tests used to examine the bowel and to diagnose bowel cancer are colonoscopy and barium enema. A new test that is being looked at is CT colonography. This is also called a 'virtual colonoscopy’. This may be particularly good for picking up bowel cancers. And it may be safer and a more acceptable test for patients.

This trial will compare virtual colonoscopy with colonosocopy and barium enema. It will look at the results of these tests, the side effects and the impact on quality of life. The researchers hope to find out whether virtual colonoscopy

Can help to diagnose bowel cancer as well as the standard tests
Is a safer test
Is more acceptable for patients

Please note this trial is no longer recruiting patients.

Recruitment

Start 01/02/2004

End 31/12/2007

Phase

Other

Who can enter

You can enter this trial if you

Have bowel symptoms and your doctor has recommended that you have either a colonoscopy or a barium enema
Are a patient at one of the centres taking part
Are well enough to have laxatives in preparation for your test
Are 55 years or older

You cannot enter this trial if you

Have Familial Adenomatous Polyposis or HNPCC
Have been found to have a faulty gene which puts you at an increased risk of developing cancer
Have Crohn's disease or ulcerative colitis
Have had treatment for bowel cancer
Have had a colonoscopy in the last 6 months

Trial design

This trial will recruit about 6000 people. There are 2 groups and it is randomised. This means that the people taking part are put into the different groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have a virtual colonoscopy. Your doctor will discuss the results with you and talk about treatment if appropriate.

If you are in group 2, you will either have a barium enema or a colonosocopy. The type of test you have will depend on the facilities in your hospital. Your doctor will discuss the results with you and talk about treatment if appropriate.

Hospital visits

Patients in both groups will be given specific instructions about what you should and should not eat and drink before your tests. You will also be told when to take your laxatives. This makes sure that your bowels are empty so that the doctor can carry out the tests.

You will have these tests as a day patient. Before you go home, you will be given an appointment to go back to the hospital for your results.

Side effects

Tests have possible side effects. A colonoscopy can be uncomfortable. During the test, there is a small risk of tearing the bowel wall. If this happens, it is treated with surgery and antibiotics.

A barium enema is sometimes uncomfortable. You may become constipated in the days following the test. Your doctor may give you laxatives to take home in case this happens.

A virtual colonoscopy may be uncomfortable when the doctor pumps air into your back passage. This is done so that the doctor can see your bowel clearly.