Kidney Calculi, Nephrolithotomy, Percutaneous
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREwithout reverse ureteral catheter insertion
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.
Sponsors
The First Affiliated Hospital of University of South China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with kidney stones who met the indications for PCNL surgery. * the maximum diameter of calculi was less than 35 mm. * the width of hydronephrosis effusion was less than 25mm.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hydrothorax | Day 2 after the surgery | Hydrothorax appeared on the surgical side. |
| Hematocrit change value | Day 2 before surgery、hour 3 after the surgery | The change value of Hematocrit between preoperative and postoperative |
| Rate of renal subcapsular hematoma | Day 2 after the surgery | The proportion of postoperative renal subcapsular hematoma in all patients |
| Serum creatinine change value | Day 2 before surgery、Hour 3 after the surgery | The change value of Serum creatinine between preoperative and postoperative |
| visual analog scale (VAS)pain score | Hour 2 after the surgery | 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. |
| Rate of fever | From the day of surgery to the day of discharge, up to 2 weeks. | Fever was defined as axillary temperature greater than 38.5 ° C. |
| White blood cell count change value | Day 2 before surgery、hour 3 after the surgery | The change value of White blood cell count between preoperative and |
| Neutrophils granulocyte change value | Day 2 before surgery、hour 3 after the surgery | The change value of Neutrophils granulocyte between preoperative and postoperative |
| Hemoglobin change value | Day 2 before surgery、hour 3 after the surgery | The change value of Hemoglobin between preoperative and postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | During the procedure | Operation time was defined as the time required from the surgeon's handwashing to the completion of surgical incision suture. |
| length of hospital stay | 2 weeks after surgery | Length of hospital stay indicated the number of days between the operation date and discharge date |
| Medical costs | 2 weeks after surgery | All medical expenses incurred to treat stones. |
| Stone free rate | Day 2 after the surgery | Residual stone less than 4mm in diameter was considered to have been cleared. |
Countries
China
Contacts
Primary ContactMingyong Li, MD.
Outcome results
None listed