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| Name | Class |
|---|---|
| Olympus | INDUSTRY |
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Magnetic Endoscope Imaging (MEI) is an optional tool which can be switched on at the beginning of colonoscopy. MEI works by creating an electromagnetic field of very low intensity. By that the position of the endoscope can be displayed virtually on a monitor. The use of MEI has been shown to reduce the formation of loops and to ease the removal of existing loops during the investigation. Furthermore, as loops favour the occurrence of pain when the scope is moved forward, patients who underwent colonoscopy with MEI reported less pain at the end of the procedure.
Sedation is used widely during colonoscopy for it has improved the tolerability of the investigation. Most of the patients demand for sedation. In Germany Propofol is recommended as the first-line sedative when endoscopy it is performed in an outpatient setting. The use of Propofol involves the danger of respiratory complications. One reason for the application of Propofol doses is the occurrence of pain during the investigation. We hypothesized that if MEI is used and if loops can be avoided sufficiently lower Propofol doses would be needed. We therefore planned this prospective controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controll Group | No Intervention | Patients from the control group will be examined using a CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope. The Magnetic Endoscope Imaging (Scope Guide) function WILL NOT BE USED during the investigation. | |
| Intervention | Active Comparator | Patients from the control group will be examined using a CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope. The Magnetic Endoscope Imaging (Scope Guide) function WILL BE USED during the investigation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Endoscope Imaging (Scope Guide) | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Propofol dose | At the end of colonoscopy total dose of Propofol applicated will be assessed. | up to one day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxemia | Oxygen saturation will be measured for the duration of colonoscopy/hospital stay. | up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day) |
| Adenoma detection rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Klare, MD | II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany | Principal Investigator |
| Stefan von Delius, MD | Klinikum rechts der Isar der Technischen Universität München | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München | München | Deutschland | 81675 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27441684 | Derived | Klare P, Hartrampf B, Haller B, Schlag C, Geisler F, Abdelhafez M, Einwachter H, Bajbouj M, Schmid RM, von Delius S. Magnetic endoscope imaging for routine colonoscopy: impact on propofol dosage and patient safety - a randomized trial. Endoscopy. 2016 Oct;48(10):916-22. doi: 10.1055/s-0042-110933. Epub 2016 Jul 21. |
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| up to one day |