7.5F Versus 9.2F Flexible Ureteroscopy for the Treatment of 1-2cm Renal Calculi on Postoperative Infection

Study Overview
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Brief Summary
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Ureteroscopic lithotripsy (RIRS) is the first-line treatment for 1-2 cm upper urinary tract stones, and the stone clearance rate can reach 81.4% - 92.5%. Fever after RIRS is the most common infection after RIRS, and its incidence is up to 20%. The incidence rate of systemic inflammatory response syndrome is 6.5% - 10.3%, sepsis 0.1% - 4.3%, with the infection progressed. If there is no timely and effective intervention in the early stage of urogenic sepsis, it can progress to septic shock, and the mortality can be as high as 30% - 40%. High intrarenal pressure is an important risk factor for postoperative infection. American Urological Association (AUA) guidelines point out that controlling intrarenal pressure at an appropriate level is particularly important to prevent postoperative infection. The use of ureteroscopic sheath in ureteroscopic surgery can effectively reduce the intrarenal pressure, which is an important measure to reduce the incidence of postoperative infection. Theoretically, the larger the space, the better the reflux effect and the lower the incidence of postoperative infection. The study showed that the incidence of ureteral sheath infection was significantly lower than that of ureteral sheath infection after operation. When using the same caliber ureteroscopic sheath, use a smaller caliber ureteroscopy to increase the space between the ureteroscopy and the ureteral sheath, promote reflux, reduce intrarenal pressure and reduce the incidence of postoperative infection. However, there is still a lack of relevant research on the effect of different caliber ureteroscopy in the treatment of renal calculi on postoperative infection.

Official Title
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7.5F Versus 9.2F Flexible Ureteroscopy for the Treatment of 1-2cm Renal Calculi on Postoperative Infection:An International Multicenter Randomized Controlled Trial

Conditions
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Kidney Stones

Intervention / Treatment
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* Procedure: 7.5fr ultra-fine ureteroscopy
* Procedure: 9.2fr Ureteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Agree to receive ureteroscopy Aged 18-70 years. 3.1-2cm kidney stones Exclusion Criteria: Combined with middle and lower ureteral calculi, surgical operation other than RIRS is required; Patients with abnormal anatomical structure, ureteral stenosis and urinary diversion, such as ectopic kidney, horseshoe kidney and duplicate kidney; Patients who have undergone nephrostomy; Severe cardiopulmonary insufficiency; Pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Patients in Group 0 undergo 7.5fr ultra-fine ureteroscopy<br> | Procedure: 7.5fr ultra-fine ureteroscopy<br>* The patient placed the lithotomy position, placed the ureteroscope to explore the affected ureter, retrogradely placed the guide wire, and placed the 12 / 14fr ureteral sheath under X-ray monitoring until the affected ureter was close to the outlet of the renal pelvis. Group 1 patients used 7.5fr ultra-fine ureteroscopy<br>|
| Experimental: Experimental: Patients in Group 2 undergo 9.2fr ureteroscopy<br> | Procedure: 9.2fr Ureteroscopy<br>* The patient placed the lithotomy position, placed the ureteroscope to explore the affected ureter, retrogradely placed the guide wire, and placed the 12 / 14fr ureteral sheath under X-ray monitoring until the affected ureter was close to the outlet of the renal pelvis. Group 2 patients used 9.2fr Ureteroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative fever | Postoperative fever was defined as armpit temperature ≥38C | ≤ 1month postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate (SFR) | 2mm Non-contrast CT is obtained for all patients at one month after removing the pigtail stent to evaluate the final SFR. Stone-free status are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the kidney which were definded as ≤ 4mm, asymptomatic, non-obstructive and non-infectious stone particles | 1 month after removing the pigtail stent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ureteroscopy, postoperative fever, renal calculi