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The current study aims to compare the performance of three distinct single-use digital flexible ureteroscope types in terms of cost-effectiveness, postoperative complications, operating time, and stone-free rates (SFRs).
Retrograde intrarenal surgery (RIRS) is the preferred treatment modality for renal stones measuring less than 20 millimeters (mm). Several types of flexible ureteroscopes are currently available on the market from different manufacturers. However, there is a shortage of comparative studies evaluating the performance of different single-use flexible ureteroscopes.
This study aims to compare the performance of three different single-use digital flexible ureteroscopes in terms of cost-effectiveness, postoperative complications, operative time, and stone-free rates (SFRs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LithoVue™ (Boston Scientific Corporation) | Active Comparator | Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the LithoVue™ single-use digital flexible ureteroscope. |
|
| WiScope® (OTU Medical Inc. (Silicon Valley, USA)) | Active Comparator | Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the WiScope® single-use digital flexible ureteroscope. |
|
| Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.) | Active Comparator | Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the single-use digital flexible ureterorenoscope manufactured by Scivita Medical Technology Co., Ltd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LithoVue™ (Boston Scientific Corporation) | Device | Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the LithoVue™ single-use digital flexible ureteroscope. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness of single-use flexible ureteroscopes | Comparison of total procedural cost and stone-free rate among three single-use flexible ureteroscopes used in retrograde intrarenal surgery (RIRS). | 4 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time and Postoperative Complications | Incidence of postoperative complications within the postoperative period. | up to 4 weeks postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hesham E Khayrallah, Resident | Contact | +201016704043 | heshamkhayrallah111@gmail.com | |
| Ashraf M Satour, Lecturer | Contact | +201050505463 |
| Name | Affiliation | Role |
|---|---|---|
| Hesham E Khayrallah, Resident | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University hospital | Recruiting | Cairo | 11566 | Egypt |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| WiScope® (OTU Medical Inc. (Silicon Valley, USA)) | Device | Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the WiScope single-use digital flexible ureteroscope. |
|
| Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.) | Device | Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the single-use digital flexible ureterorenoscope manufactured by Scivita Medical Technology Co., Ltd. |
|
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |