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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| without reverse insertion of a ureteral catheter | Experimental | Percutaneous nephrolithotomy without reverse insertion of a ureteral catheter |
|
| Conventional | No Intervention | Percutaneous nephrolithotomy with reverse insertion of a ureteral catheter |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCNL without reverse insertion of a ureteral catheter | Procedure | The ureteral catheter was not retrograde inserted during PCNL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of fever | Fever was defined as axillary temperature greater than 38.5 ° C. | 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 | Day 2 before surgery、hour 3 after the surgery |
| Neutrophils granulocyte change value | The change value of Neutrophils granulocyte between preoperative and postoperative | Day 2 before surgery、hour 3 after the surgery |
| Hemoglobin change value | The change value of Hemoglobin between preoperative and postoperative | Day 2 before surgery、hour 3 after the surgery |
| Hematocrit change value | The change value of Hematocrit between preoperative and postoperative | Day 2 before surgery、hour 3 after the surgery |
| Rate of renal subcapsular hematoma | The proportion of postoperative renal subcapsular hematoma in all patients | Day 2 after the surgery |
| Serum creatinine change value | The change value of Serum creatinine between preoperative and postoperative | Day 2 before surgery、Hour 3 after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Stone free rate | Residual stone less than 4mm in diameter was considered to have been cleared. | 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 |
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Inclusion Criteria:
· Patients with upper urinary tract stones who were 18 years of age or older and eligible for PCNL surgery.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingyong Li, MD. | Contact | 137-8648-4606 | +86 | myli1123@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Mingyong Li, MD. | the First Affiliated Hospital of the University of South China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of South China | Recruiting | Hengyang | Hunan | 421001 | China |
Individual participant data will be made available to other researchers after the study Report are published.
One year after the study report was published,but the duration is uncertain.
When proper editing or review requirements are met, the study data will be available from the study manager after the study is completed.
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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. |
| Hour 2 after the surgery |
| Rate of hydrothorax | Hydrothorax appeared on the surgical side. | Day 2 after the surgery |
| During the procedure |
| length of hospital stay | Length of hospital stay indicated the number of days between the operation date and discharge date | 2 weeks after surgery |
| Medical costs | All medical expenses incurred to treat stones. | 2 weeks after surgery |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |