Percutaneous Nephrolithotomy Without a Ureteral Catheter

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.

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.

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.

Operation time was defined as the time required from the surgeon's handwashing to the completion of surgical incision suture

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.

Individual participant data will be made available to other researchers after the study Report are published.

When proper editing or review requirements are met, the study data will be available from the study manager after the study is completed.