colonic polyps
Conditions
Interventions
Colonoscopy with the Olympus Extra Wide Angle View Colonoscope
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age greater than or equal to 18 years - High risk for colorectal cancer: FOBT positive, personal or familial (first degree relatives) history of colorectal cancer or colorectal adenoma, patients with symptoms suggestive of colorectal neoplasm: rectal bleeding, recent change in frequency and consistency of stools. - Status 1 and 2 of the ASA classification (fit for colonoscopy) - Signed informed consent
Exclusion criteria
Exclusion criteria: - Mental or physical condition that can adversely affect the preparation or conduct of the examination or which precludes compliance with the study and / or device instructions. - Inability to undergo bowel cleansing for colonoscopy. - Prior abdominal surgery of the gastrointestinal tract (other than uncomplicated appendectomy or cholecystectomy). - Known or suspicion of inflammatory bowel disease. - Known large (> 2 cm) colorectal polyp for polypectomy - Colonic diverticulosis complication within 3 months prior inclusion. - Very high risk for colorectal cancer, history of extensive polyposis, patients with known genetic disease (Familial Adenomatous Polyposis (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC)). - Coagulation abnormalities or taking drugs affecting coagulation. - Life threatening conditions - Status > 2 of the ASA classification (see Appendix I). - Renal insufficiency or any contraindication or medication contraindicating the administration of bowel cleansing. - Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception. - Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adenoma detection rate of the Olympus Extra Wide Angle View colonoscope | — |
Secondary
| Measure | Time frame |
|---|---|
| - Sensitivity of the Olympus Extra Wide Angle View colonoscope for the detection of advanced colorectal adenomas in comparison to data from the Exera III study, overall and in subgroups (adenoma size, form, location). - Evaluation of caecal insertion time using the Olympus Extra Wide Angle View colonoscope with responsive insertion technology in compariso to caecal insertion times gained during the Exera III study. - Evaluation of ileocaecal valve insertion success using the Olympus Extra Wide Angle View colonoscope in comparison to ileocaecal valve insertion success gained during the Exera III study. - Evaluation of retroflex view using the Olympus Extra Wide Angle View colonoscope in comparison to the retroflex view gained during the Exera III study. - Adverse events of the Olympus Extra Wide Angle View colonoscope in comparison to the Exera III study. | — |
Countries
Netherlands
Outcome results
None listed