Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter

Study Overview
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Brief Summary
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Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi. The advent of tubeless PCNL (without indwelling nephrostomy tube) has been proved to be safe and effective in reducing postoperative discomfort, shortening hospitalization time and reducing hospitalization costs. Traditional tubeless PCNL usually involves retrograde insertion of the ureteral catheter, which may cause many ureteral related surgical complications. However, there are few reports on tubeless PCNL without reverse ureteral catheter insertion. The goal of this study is to explore the safety and effectiveness of the tubeless PCNL without reverse ureteral catheter insertion.

Detailed Description
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This is a key clinical research project of the University of South China (No. USCKF201902K01). The goal of this study is to comparative the safety and clinical efficacy between the tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter and the traditional tubeless percutaneous nephrolithotomy with reverse insertion of a ureteral catheter in the treatment of upper urinary calculi, and to explore the former' applications. It is a prospective, randomized controlled single center study that is conducted for 2 years anticipatively. The clinic physician is responsible for patient recruitment and allocation and the application of computerized random-number generation. For random allocation, participants are given random numbers. Participants with odd numbers are assigned to experimental group, where they undergo tubeless PCNL without reverse insertion of a ureteral catheter. Participants with even numbers are assigned to control group and undergo tubeless PCNL with reverse insertion of a ureteral catheter. The doctors managing the operations accept participants and execute the surgical treatments. All participants sign clinical-trial informed consent and surgical informed consent during the preoperative conversation. Follow-up observation is conducted for 1 month after surgery. After completion of the study, we collect relevant clinical data from the participants. The primary and secondary outcomes are analyzed and compared between the two groups.

Official Title
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A Comparative Study of Tubeless Percutaneous Nephrolithotomy With or Without Reverse Ureteral Catheter Insertion

Conditions
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Urinary Calculi, Percutaneous Nephrolithotomy

Intervention / Treatment
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* Procedure: Without reverse insertion of a ureteral catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who met the the applications of PCNL surgery in the 2019 Chinese Guidelines for the Diagnosis and Treatment of Urological Diseases Participants who agree to undergo tubeless PCNL The participants' maximum diameter of the stone should be less than 3.5cm Exclusion Criteria: Confirmation by computerized tomography (CT) images and blood biochemical indicators of infectious stones or complex staghorn stones Obvious surgical contraindications, such as severe heart and lung insufficiency, abnormal coagulatory function Previous PCNL or nephrolithotomy, presence of an indwelling ureteral stent or nephrostomy tube before surgery Renal trauma or congenital malformation of the urinary system

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to an experimental or control group in parallel.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group(group 1)<br>Without reverse insertion of a ureteral catheter in tubeless percutaneous nephrolithotomy. | Procedure: Without reverse insertion of a ureteral catheter<br>* Traditional tubeless percutaneous nephrolithotomy usually need retrograde ureteral catheter insertion. Our intervention is that the tubeless percutaneous nephrolithotomy is executed without reverse insertion of a ureteral catheter.<br>|
| No Intervention: Control group(group 2)<br>Traditional tubeless percutaneous nephrolithotomy need reverse insert a ureteral catheter. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of inflammatory indicators after surgery | Pre- vs. post-operative blood leukocyte counts and neutrophil-ratio difference | Hour 3 after the surgery | 
| Changes in renal bleeding after surgery | Pre- vs. post-operative difference in hemoglobin and hematocrit values | Hour 3 after the surgery | 
| Changes of renal-function after surgery | Preoperative and postoperative blood creatinine difference | Hour 3 after the surgery | 
| Pain score after surgery | According to the Visual Analogue Scale(VAS) to evaluate the score. Scores range from 0 to 10, where 0 represents no pain and 10 represents the highest pain. | Hour 3 after the surgery | 
| Incidence of pneumothorax and hydrothorax | The rate of pneumothorax and hydrothorax after surgery | Day 2 after the surgery | 
| Incidence of ureteral stone street | The rate of ureteral stone street after surgery | Day 2 after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of operation | From the completion of anesthesia to the end of the suture incision. | during the procedure | 
| Duration of hospital stay | From the date of admission to the date of discharge. | immediately after the discharge | 
| Hospital costs | The cost from hospitalization to discharge. | immediately after the discharge | 
| Stone-free rates | Preoperative and postoperative stone dimensions are compared by radiological assessment. Postoperative residual calculi < 4 mm in diameter reflect complete removal of calculi (stone-free rate = 100%). | Day 2 after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureteral catheter, Without reverse insertion, Percutaneous nephrolithotomy, Tubeless, Urinary calculi