Kidney Calculi, Nephrolithotomy Percutaneous
Conditions
Brief summary
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
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.
Interventions
PROCEDUREPCNL without reverse insertion of a ureteral catheter
The ureteral catheter was not retrograde inserted during PCNL
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine change value | Day 2 before surgery、Hour 3 after the surgery | The change value of Serum creatinine between preoperative and postoperative |
| 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 |
| 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 |
| Rate of hydrothorax | Day 2 after the surgery | Hydrothorax appeared on the surgical side. |
| 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 postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
China
Contacts
Primary ContactMingyong Li, MD.
Outcome results
None listed