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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Oslo University Hospital | OTHER |
| University of Oslo | OTHER |
| Showa University |
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PURPOSE OF PROTOCOL
Objective:
To evaluate if the speedometer based on the real-time image analysis can help endoscopists increase their withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, during colonoscopy.
Hypothesis:
The trial hypothesis is that use of the speedometer during colonoscopy will increase the average withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, by 1.6 minutes, possibly increasing the performance of the participating endoscopists. Our objective is to clarify the clinical benefits of this digital tool in colonoscopy.
Endpoint: Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy with the speedometer | Active Comparator |
| |
| Colonoscopy without the speedometer | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Speedometer | Device | We will measure and monitor the withdrawal time of colonoscopy with a speedometer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Withdrawal time | Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period). | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate (ADR) | Adenoma detection rate (ADR) of the participating endoscopists during the control period and the intervention period. | Through study completion, an average of 1 year |
| Quality of colonoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36519564 | Derived | Barua I, Misawa M, Glissen Brown JR, Walradt T, Kudo SE, Sheth SG, Nee J, Iturrino J, Mukherjee R, Cheney CP, Sawhney MS, Pleskow DK, Mori K, Loberg M, Kalager M, Wieszczy P, Bretthauer M, Berzin TM, Mori Y. Speedometer for withdrawal time monitoring during colonoscopy: a clinical implementation trial. Scand J Gastroenterol. 2023 Jun;58(6):664-670. doi: 10.1080/00365521.2022.2154616. Epub 2022 Dec 15. |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
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Proportion of colonoscopies with withdrawal time ≥ 6 minutes.
| Through study completion, an average of 1 year |