Extrait

Background and study aims Bowel (or colorectal) cancer is one of the most common types of cancer. If a person is suspected to have colorectal cancer, they may undergo a colonoscopy, an examination of the bowel using a device called a colonoscope. A colonoscope is a flexible tube that is attached to a camera and a light. It is inserted into the bowel though the rectum. The tube is pushed through the entire length of the bowel and is then slowly taken out again (withdrawn). The bowel is examined for signs of cancer (the presence of adenomas and polyps) during withdrawal. The EndoRings is a flexible silicone rubber device that can be attached to the end of a colonoscope. It has circular wings that stretch the walls of the colon and flatten them. This, in turn, increases how much of the colon that can be seen during a colonoscopy. Previous studies have shown that EndoRings colonoscopy is more likely to detect adenomas and polyps and are less likely to miss them (miss rate) than standard colonoscopy. This study is comparing the diagnostic yield (that is, how many patients are diagnosed with bowel cancer) and the number of adenomas and polyps are missed (the miss rate) of EndoRings colonoscopy with standard colonoscopy. Who can participate? Adults that have tested positive in respect to a immunochemical fecal test as part of a screening program to detect bowel cancer. What does the study involve? Participants are randomly assigned to one of four groups. Those in group 1 are given a standard colonoscopy. Those in group 2 are given a EndoRings colonoscopy. Those in group 3 are given a standard colonoscopy followed by a EndoRings colonoscopy (one immediately after the other). Those in group 4 are given a EndoRings colonoscopy followed immediately by a standard colonoscopy. If any adenomas or polyps are identified during the procedures they are removed and analysed if appropriate. All patients are then called 30 days after the examination and asked about their experience. What are the possible benefits and risks of participating? The possible benefit to participating in this study is the identification of precancerous lesions (for example, polyps), leading to a reduced risk of developing CRC. No risks are expected. Where is the study run from? Regina Margherita Hospital, Rome (Italy) When is the study starting and how long is it expected to run for? April 2016 to January 2018 Who is funding the study? Investigator initiated and funded Who is the main contact? Dr Cesare Hassan [email protected]

Critère d'inclusion

• Colorectal adenomas and serrated polyps

Liens

• isrctn