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The goal of this observational study is to learn about the effects of using negative pressure suction during retrograde intrarenal surgery (RIRS) in patients aged 18 and older with kidney stones. The main questions it aims to answer are:
Participants will undergo their scheduled kidney stone surgery as part of their regular medical care. Researchers will collect their routine clinical data from the hospital system, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Suction Sheath Group | Patients who undergo retrograde intrarenal surgery (RIRS) using a ureteral access sheath with a negative pressure suction system. | ||
| Standard Ureteral Access Sheath Group | Patients who undergo retrograde intrarenal surgery (RIRS) using a standard ureteral access sheath without a negative pressure suction system. |
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| Measure | Description | Time Frame |
|---|---|---|
| Volume of irrigation fluid absorbed | Intraoperative (During the surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative fever and infectious complication | Up to 7 days postoperatively | |
| ostoperative length of hospital stay | From surgery to hospital discharge (an average of 3-7 days) | |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (typically aged 18 years and older) diagnosed with renal and/or upper ureteral stones who are scheduled to undergo retrograde intrarenal surgery (RIRS) at the urology department.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiping Wang | Contact | 13893131697 | wangzplzu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lanzhou University Second Hospital | Recruiting | Lanzhou | Gansu | 730030 | China |
The clinical data involves sensitive patient privacy. We are currently undecided on sharing the IPD, as it requires specific informed consent from the patients and authorization from the hospital's ethics committee.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2025 | Mar 19, 2026 | Prot_SAP_000.pdf |
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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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| Stone-free rate (SFR) |
| 1 month postoperatively |
| 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 |