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This study evaluates the safety and efficacy of the suctioning flexible ureteroscopy(SF-URS) with automatic control of renal pelvic pressure for the treatment of upper urinary calculi using a prospective, randomized design. Half of participants will receive suctioning flexible ureteroscopy with automatic control of renal pelvic pressure, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscopy.
Retrograde intrarenal surgery using flexible ureteroscope has become the first-line treatment for renal calculi < 3.0 cm and is recommended by the European Association of Urology due to its minimally-invasive nature and satisfactory result.
However, high perfusion rate leads to renal pelvic pressure increase, resulting in absorption of liquid, bacteria, and endotoxin into blood, followed by short-term complications such as systemic inflammatory response syndrome(SIRS , 8.1%), sepsis (0-4.5%), renal pelvic and ureteral tumor spread, and long-term complication of renal function impairment. Currently the commonly used flexible ureteroscope sheath (ureteral access sheath, UAS) reduces the renal pelvic pressure to a certain extent, but still can not control and monitor the renal pelvic pressure to reduce the incidence of complications, which, limit the clinical application of ureteroscopy.
Recently, the investigators present a novel technique of SF-URS with automatic control of renal pelvic pressure. In this study, transverse comparison is designed to evaluate the safety and efficacy of the suctioning flexible ureteroscopy with automatic control of renal pelvic pressure for the treatment of renal calculi.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SF-URS with automatic control of RPP | Experimental | Participants in SF-URS with automatic control of renal pelvic pressure (RPP) group undergo ureteroscopy using the intelligent pressure control device (Medical irrigation and suctioning platform with pressure feedback function, and suctioning ureteral access sheath with function of pressure measuring). |
|
| conventional F-URS | Active Comparator | Participants in conventional F-URS group undergo ureteroscopy using the classic flexible ureteroscope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SF-URS with automatic control of RPP | Device | A new F-URS monitoring and control of RPP using intelligent pressure control device |
|
| Measure | Description | Time Frame |
|---|---|---|
| stone-free rate | Number of participants undergo novel or conventional F-URS surgeries without residual calculus/Total number of participants in each group *100% | 4 weeks post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| stone-free rate | Number of participants undergo novel or conventional F-URS surgeries without residual calculus/Total number of participants in each group *100% | One day post-operatively |
| Complication rates |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| conventional F-URS | Device | Ureteroscopy will be conducted using the ureteral access sheath from Cook Medical to treat renal calculi. |
|
Number of participants undergo novel or conventional F-URS surgeries suffer complications associated with the surgery (i.e. pain(NRS≥4), hematuria, T≥38℃, serum white blood cell≥12×〖10〗^9/L ,serum white blood cell<4×〖10〗^9/L, perforation, etc.)/Total number of participants in each group *100%
| Within 4 weeks after surgery |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |