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| ID | Type | Description | Link |
|---|---|---|---|
| 21835 (NSD) - 3 | Other Identifier | Norway: Norwegian Social Science Data Services | |
| 102.09 (REK) - 3 | Other Identifier | The National Committees for Research Ethics in Norway |
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Withdrawn. Not enough time to go through with the study.
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The purpose of this study is to investigate the impact of a safety guidewire (SGW) on the results of ureteroscopy for urolithiasis.
Study hypothesis: Routine use of SGW has no impact on the results of ureteroscopic treatment of urolithiasis.
The use of SGW is generally recommended at any ureteroscopic procedure in order to facilitate the introduction of the endoscope and to secure placement of internal tubes for drainage of urine after the procedure.
However, SGW may be an obstacle to efficient disintegration and retraction of calculi in the narrow ureter.
The intention of this study is to compare the results of endoscopic stone treatment with and without the use of SGW.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B - without SGW | Active Comparator | Ureteroscopy without SGW in place. |
|
| A - with SGW | Active Comparator | Ureteroscopy with SGW in place. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ureteroscopy with and without safety guidewire | Procedure | In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW. |
| Measure | Description | Time Frame |
|---|---|---|
| Stone free-rate | 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay | Up to 1 week after the operation | |
| Complication rate | Until 3 months after the procedure | |
| Operating time |
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Inclusion 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 |
|---|---|
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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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| Up to 1 day after the surgery |
| D052801 | Male Urogenital Diseases |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |