About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Without reverse insertion of a ureteral catheter
Procedure/SurgeryTraditional 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.
Treatment groups
Trial outcomes
Primary outcomes
Changes of inflammatory indicators after surgery
Pre- vs. post-operative blood leukocyte counts and neutrophil-ratio difference
Changes in renal bleeding after surgery
Pre- vs. post-operative difference in hemoglobin and hematocrit values
Changes of renal-function after surgery
Preoperative and postoperative blood creatinine difference
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.
Secondary outcomes
Duration of operation
From the completion of anesthesia to the end of the suture incision.
Duration of hospital stay
From the date of admission to the date of discharge.
Hospital costs
The cost from hospitalization to 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%).
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