Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial

Conditions
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Colorectal Cancer, Adenomas

Intervention / Treatment
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* Device: Olympus PCF-Y0014-L
* Device: Standard colonoscope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 54 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prototype colonoscope<br>The new colonoscope to be tested | Device: Olympus PCF-Y0014-L<br>* Screening colonoscopy with a prototype colonoscope<br>* Other names: Olympus PCF-Y0014-L colonoscope;|
| Active Comparator: Standard colonoscope<br>The standard colonoscope used world-wide today. | Device: Standard colonoscope<br>* Screening colonoscopy<br>* Other names: Olympus series 160 colonoscope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients´ evaluation of pain and discomfort | Analysis of validated feed-back questionnaires to be filled in on the day after the proceudre by the trial participants. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time used to reach the caecum | The time used to reach the caecum will be recorded with a stop watch during the procedure. | 1 hour | 
| Need for sedation/analgesics during the colonoscopy procedure | If sedation/analgesics is administered during the colonoscopy procedure, the name of the agent, dose and route of administration will be recorded immediately. | 1 hour | 
| Need to change to a different colonoscope to complete the procedure | 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. | 10 minutes | 
| Caecum intubation rate | The colonic segment reached during each colonoscopy is recorded immediately following the procedure. Caecal intubation rate describes the number of complete colonoscopies. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy performance, Pain, Discomfort, Screening, Colorectal cancer, Colorectal cancer screening, diagnostics of adenomas