Total Tubeless Percutaneous Nephrolithotomy Without a Ureteral Catheter

Study Overview
=================
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.

Official Title
-----------------
A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Total Tubeless Percutaneous Nephrolithotomy

Conditions
-----------------
Nephrolithotomy, Percutaneous, Kidney Calculi

Intervention / Treatment
-----------------
* Procedure: without reverse ureteral catheter insertion


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter<br>In total tubeless percutaneous nephrolithotomy surgery, there is no reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, no need to change the position, and no need to re-sterilize and lay towels. | Procedure: without reverse ureteral catheter insertion<br>* 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.<br>|
| No Intervention: Conventional total tubeless percutaneous nephrolithotomy<br>In total tubeless percutaneous nephrolithotomy surgery, there is reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, need to change the position, and need to re-sterilize and lay towels. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |