Percutaneous Nephrolithotomy Without a Ureteral Catheter

Study Overview
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Brief Summary
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Conventional Percutaneous nephrolithotomy (PCNL) surgery requires the patient to first undergo retrograde transurethral ureteroscopic insertion of the ureteral catheter in the lithotomy position, and then change the patient to the prone position. However, repeated operation on the ureter can bring about immediate and long-term negative effects, such as ureteral false way formation, ureteral damage, perforation, avulsion, catheter insertion into the vena cava, pricking the kidney, increased postoperative pain, urinary extravasation, scar formation, and ureteral narrowing. The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the PCNL surgery.

Detailed Description
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The purpose of this single-center, single-blind, randomized trial was to evaluate the safety and efficacy of PCNL without reverse insertion of a ureteral catheter. It is planned to start in November 2022 and is expected to end in November 2024. Based on inclusion and exclusion criteria, 200 subjects were expected to be recruited. In a parallel group design, subjects were randomly assigned to two groups: the experimental group received PCNL without reverse insertion of a ureteral catheter , and the control group received traditional PCNL. The primary end point of the study was the incidence of postoperative complications according to the modified Clavien-Dindo complication grading system. Secondary end points included Stone-free rate, operation time, length of hospital stay, and medical costs. Measurement data were expressed as mean ± standard deviation (X ± S), and Student's t-test was used for intergroup comparisons. The counting data were expressed as frequency and percentage, and the chi-squared or Fisher's exact probability test were used for intergroup comparisons. The rank-sum test was used for grade data. P<0.05 was considered statistically significant.

Official Title
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A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Percutaneous Nephrolithotomy

Conditions
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Nephrolithotomy Percutaneous, Kidney Calculi

Intervention / Treatment
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* Procedure: PCNL without reverse insertion of a ureteral catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: · Patients with upper urinary tract stones who were 18 years of age or older and eligible for PCNL surgery. Exclusion Criteria: patients with infectious calculi confirmed by preoperative CT examination and blood biochemical indexes. Patients with severe cardiac and pulmonary insufficiency, coagulation dysfunction and other obvious surgical contraindications. Patients with previous history of PCNL surgery on the affected side or nephrotomy. Patients with indwelling double J tube or nephrostomy tube before operation. Patients with renal trauma or congenital anomalies of urinary system.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: without reverse insertion of a ureteral catheter<br>Percutaneous nephrolithotomy without reverse insertion of a ureteral catheter | Procedure: PCNL without reverse insertion of a ureteral catheter<br>* The ureteral catheter was not retrograde inserted during PCNL<br>|
| No Intervention: Conventional<br>Percutaneous nephrolithotomy with reverse insertion of a ureteral catheter | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of fever | Fever was defined as axillary temperature greater than 38.5 ° C. | From the day of surgery to the day of discharge, up to 2 weeks. | 
| White blood cell count change value | The change value of White blood cell count between preoperative and postoperative | Day 2 before surgery、hour 3 after the surgery | 
| Neutrophils granulocyte change value | The change value of Neutrophils granulocyte between preoperative and postoperative | Day 2 before surgery、hour 3 after the surgery | 
| Hemoglobin change value | The change value of Hemoglobin between preoperative and postoperative | Day 2 before surgery、hour 3 after the surgery | 
| Hematocrit change value | The change value of Hematocrit between preoperative and postoperative | Day 2 before surgery、hour 3 after the surgery | 
| Rate of renal subcapsular hematoma | The proportion of postoperative renal subcapsular hematoma in all patients | Day 2 after the surgery | 
| Serum creatinine change value | The change value of Serum creatinine between preoperative and postoperative | Day 2 before surgery、Hour 3 after the surgery | 
| visual analog scale (VAS)pain score | 0: no pain; Less than 3 points: mild pain, tolerable; 4 points to 6 points: the patient's pain and affect sleep, still tolerable; 7-10: Patients have increasing pain, pain is unbearable, affect appetite, affect sleep. | Hour 2 after the surgery | 
| Rate of hydrothorax | Hydrothorax appeared on the surgical side. | Day 2 after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate | Residual stone less than 4mm in diameter was considered to have been cleared. | Day 2 after the surgery | 
| Operation time | Operation time was defined as the time required from the surgeon's handwashing to the completion of surgical incision suture | During the procedure | 
| length of hospital stay | Length of hospital stay indicated the number of days between the operation date and discharge date | 2 weeks after surgery | 
| Medical costs | All medical expenses incurred to treat stones. | 2 weeks after surgery |