Colorectal Cancer, Screening
Conditions
Keywords
Colonoscopy, Colorectal cancer, Adenoma
Brief summary
Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for different reasons, and features of the colonoscope and the use of imaging devices may influence the success rate. We want to compare the performance of a new colonoscope with novel features including gradual stiffness with that of a colonoscope supplied with a magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new instrument is non-inferior to the MEI system.
Detailed description
The recommended cecal intubation rate in colorectal cancer (CRC) screening is 95%. The MEI system allows real time monitoring of the colonoscope position within the colon and is considered to be a useful supplement to achieve cecal intubation. However, the MEI system is costly, and trial results are equivocal regarding the actual benefits. A newly designed colonoscope (ColoAssist) with gradual stiffness throughout the colonoscope shaft has been developed to improve insertability. We want to investigate if we can achieve equal performance results with the ColoAssist instrument as with the MEI system in CRC screening. The study is designed as a two-center, single-blinded, randomized, controlled non-inferiority trial.
Interventions
DEVICEColoAssist
Screening colonoscopy with the test instrument
DEVICEMEI
Colonoscopy with Olympus colonoscopes and MEI guidance
Sponsors
Sorlandet Hospital HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to 66 Years
Healthy volunteers
Yes
Inclusion criteria
* Inclusion in an ongoing colorectal cancer screening trial (NCT 00883792)
Exclusion criteria
* Excluded from the ongoing screening trial (NCT 00883792) * Inability or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cecal intubation rate | 1 hour | The ability to reach the cecum during colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cecal intubation time | 1 hour | Time to reach the cecum during colonoscopy |
| Adenoma detection rate | 1 hour | The proportion of participants in whom at least one adenoma is detected |
| Polyp detection rate | 1 hour | The proportion of participants in whom at least one polyp i detected |
| Pain | 24 hours | Participants will be asked to score discomfort or pain during and after colonoscopy |
Countries
Norway
Outcome results
None listed