Colorectal Cancer, Adenomas
Conditions
Keywords
Colonoscopy performance, Pain, Discomfort, Screening, Colorectal cancer, Colorectal cancer screening, diagnostics of adenomas
Brief summary
The purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. Both colonoscopes are manufactured by the same company.
Interventions
DEVICEOlympus PCF-Y0014-L
Screening colonoscopy with a prototype colonoscope
DEVICEStandard colonoscope
Screening colonoscopy
Sponsors
Sorlandet Hospital HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
54 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Persons included in the NordICC trial are eligible for inclusion * For information about the NordICC trial see clinicaltrials.gov NCT00883792
Exclusion criteria
* Pregnancy * Persons younger than 18 years * Persons unable to comprehend the information given * not possible to start the examination without prior administration of sedation/analgesics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients´ evaluation of pain and discomfort | 24 hours | Analysis of validated feed-back questionnaires to be filled in on the day after the proceudre by the trial participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time used to reach the caecum | 1 hour | The time used to reach the caecum will be recorded with a stop watch during the procedure. |
| Need for sedation/analgesics during the colonoscopy procedure | 1 hour | If sedation/analgesics is administered during the colonoscopy procedure, the name of the agent, dose and route of administration will be recorded immediately. |
| Need to change to a different colonoscope to complete the procedure | 10 minutes | If the colonoscopist decides to change to a different colonoscope during the procedure, the reason is recorded immediately after the procedure. The number of procedures where there is a change of colonoscope will be recorded. |
| Caecum intubation rate | 30 minutes | The colonic segment reached during each colonoscopy is recorded immediately following the procedure. Caecal intubation rate describes the number of complete colonoscopies. |
Countries
Norway
Outcome results
None listed