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| ID | Type | Description | Link |
|---|---|---|---|
| 21835 (NSD) - 4 | Other Identifier | Norway: Norwegian Social Science Data Services | |
| 102.09 (REK) - 4 | Other Identifier | The National Committees for Research Ethics in Norway |
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The purpose of this study is to investigate to forces needed to passage the ureteroscope up and down the ureter with and without a safety guidewire in place.
Ureteroscopy may damage the ureter, and the complication risk is influenced by the forces needed to move the ureteroscope up and down the ureter.
Although a safety guidewire (SGW) is commonly recommended in order to reduce the complication rate it may well be that the SGW itself may inhibit the passage of the ureteroscope due to increased friction.
The forces needed to move the ureteroscope in the ureter have not been investigated properly.
The intention in this study is to measure the forces needed to advance and withdraw the ureteroscope in the ureter with and without the SGW in place.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - with SGW | Experimental | Measurement of the forces needed to passage the ureteroscope in the ureter with a SGW in place. |
|
| B - without SGW | Experimental | Measurement of the forces needed to passage the ureteroscope in the ureter without a SGW in place. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ureteroscopy with and without safety guidewire | Procedure | In study arm A - with SGW, the force measurements are made with a safety guidewire in place. In study arm B - without SGW, the force measurements are made without SGW. |
| Measure | Description | Time Frame |
|---|---|---|
| The force needed to passage the ureteroscope up and down in the ureter with and without SGW. | The force is measured by a digital force-meter device. The force measured is scaled in Newton. The results are available immediately after each measurement. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Øyvind Ulvik, MD | Helse Bergen HF, Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helse Bergen HF, Haukeland University Hospital | Bergen | Bergen | 5021 | Norway |
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| ID | Term |
|---|---|
| D018666 | Ureteroscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |