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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prototype colonoscope | Experimental | The new colonoscope to be tested |
|
| Standard colonoscope | Active Comparator | The standard colonoscope used world-wide today. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olympus PCF-Y0014-L | Device | Screening colonoscopy with a prototype colonoscope |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Bretthauer, MD, Ph.d. | Oslo University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sørlandet Sykehus HF | Kristiansand | 4604 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22622786 | Derived | Garborg KK, Loberg M, Matre J, Holme O, Kalager M, Hoff G, Bretthauer M. Reduced pain during screening colonoscopy with an ultrathin colonoscope: a randomized controlled trial. Endoscopy. 2012 Aug;44(8):740-6. doi: 10.1055/s-0032-1309755. Epub 2012 May 23. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D000236 | Adenoma |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Standard colonoscope | Device | Screening colonoscopy |
|
|
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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |