Total tubeless Percutaneous nephrolithotomy (PCNL) is a modified surgical method of PCNL surgery, that is, there is no indwelling nephrostomy tube and double-J tube during PCNL surgery. Compared with traditional PCNL surgery, it has the advantages of reducing pain, shortening operation time and reducing operation cost. Since this procedure was first performed in 2004, several randomized clinical studies have verified the safety and efficacy of total tubeless PCNL. Conventional total tubeless 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, a large number of literature reports and the surgical experience of PCNL in the past 20 years tell the investigators that the reverse insertion of ureteral catheter can cause many recent surgical complications.The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the total tubular PCNL surgery.
The purpose of this single-center, single-blind, randomized trial was to investigate whether without retrograde insertion of a ureteral catheter is appropriate for total tubeless percutaneous nephrolithotomy. It is planned to start in October 2022 and is expected to end in October 2024. Based on inclusion and exclusion criteria, 100 subjects were expected to be recruited. In a parallel group design, subjects were randomly assigned to two groups: the experimental group received total tubeless PCNL without reverse insertion of a ureteral catheter , and the control group received conventional total tubeless 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
100
In contrast to conventional total tubeless percutaneous nephrolithotomy, there was no reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, no change in position, and no repeated disinfection.
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
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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