No registrations found.
ID
Source
Brief title
Health condition
Adenoma Miss Rate during colonoscopy
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adenoma detection rate of the Olympus Extra Wide Angle View colonoscope
Secondary outcome
- 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 comparison 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.
Background summary
Colonoscopy is the gold standard for finding colorectal cancers and precursor lesions, adenomas. Unfortunately recent studies show there is still a high adenoma miss-rate with the current endoscopic techniques. Some adenomas hide behind valve and are therefore missed. Olympus developed a new device that provides the endoscopist an enlarged view. The expectation is that due to this enlarged view more adenomas are detected compared to conventional colonoscopy. The results will be compared with the results of the EXERA III study
Study objective
Increased adenoma detection rate due to the enlarged colonoscopic view
Study design
01-03-2015 data analysis
Intervention
Colonoscopy with extra wide angle view colonoscope
Klinik und Poliklinik für Interdisziplinäre Endoskopie Universitätsklinikum Hamburg-Eppendorf Martinistraße 52
D-20246
Thomas Rösch
Hamburg
Germany
t.roesch@uke.de
Klinik und Poliklinik für Interdisziplinäre Endoskopie Universitätsklinikum Hamburg-Eppendorf Martinistraße 52
D-20246
Thomas Rösch
Hamburg
Germany
t.roesch@uke.de
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 (see Appendix I)
- Signed informed consent
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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4316 |
| NTR-old | NTR4536 |
| CCMO | NL46414.018.13 |
| OMON | NL-OMON41267 |