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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
The ureteral catheter was not retrograde inserted during PCNL
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
RECRUITINGRate of fever
Fever was defined as axillary temperature greater than 38.5 ° C.
Time frame: 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
Time frame: Day 2 before surgery、hour 3 after the surgery
Neutrophils granulocyte change value
The change value of Neutrophils granulocyte between preoperative and postoperative
Time frame: Day 2 before surgery、hour 3 after the surgery
Hemoglobin change value
The change value of Hemoglobin between preoperative and postoperative
Time frame: Day 2 before surgery、hour 3 after the surgery
Hematocrit change value
The change value of Hematocrit between preoperative and postoperative
Time frame: Day 2 before surgery、hour 3 after the surgery
Rate of renal subcapsular hematoma
The proportion of postoperative renal subcapsular hematoma in all patients
Time frame: Day 2 after the surgery
Serum creatinine change value
The change value of Serum creatinine between preoperative and postoperative
Time frame: 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.
Time frame: Hour 2 after the surgery
Rate of hydrothorax
Hydrothorax appeared on the surgical side.
Time frame: Day 2 after the surgery
Stone free rate
Residual stone less than 4mm in diameter was considered to have been cleared.
Time frame: 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
Time frame: During the procedure
length of hospital stay
Length of hospital stay indicated the number of days between the operation date and discharge date
Time frame: 2 weeks after surgery
Medical costs
All medical expenses incurred to treat stones.
Time frame: 2 weeks after surgery
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