Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First Affiliated Hospital of University of South China

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Without reverse insertion of a ureteral catheter

    Procedure/Surgery

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Experimental group(group 1)Experimental treatment 1 intervention
Group B: Control group(group 2)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Changes of inflammatory indicators after surgery

Pre- vs. post-operative blood leukocyte counts and neutrophil-ratio difference

Time frame
Hour 3 after the surgery
2

Changes in renal bleeding after surgery

Pre- vs. post-operative difference in hemoglobin and hematocrit values

Time frame
Hour 3 after the surgery
3

Changes of renal-function after surgery

Preoperative and postoperative blood creatinine difference

Time frame
Hour 3 after the surgery
4

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.

Time frame
Hour 3 after the surgery

Secondary outcomes

1

Duration of operation

From the completion of anesthesia to the end of the suture incision.

Time frame
during the procedure
2

Duration of hospital stay

From the date of admission to the date of discharge.

Time frame
immediately after the discharge
3

Hospital costs

The cost from hospitalization to discharge.

Time frame
immediately after the discharge
4

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%).

Time frame
Day 2 after the surgery

Other outcomes

Sponsors and contacts

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