An interventional study of Without reverse insertion of a ureteral catheter in Urinary Calculi and Percutaneous Nephrolithotomy, sponsored by The First Affiliated Hospital of University of South China. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by The First Affiliated Hospital of University of South China · Not applicable, Interventional, and Treatment
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.
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.
94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 61 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →The First Affiliated Hospital of University of South China is the lead sponsor of 13 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Without reverse insertion of a ureteral catheter in tubeless percutaneous nephrolithotomy.
Procedure: Without reverse insertion of a ureteral catheter
Traditional tubeless percutaneous nephrolithotomy need reverse insert a ureteral catheter.
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.
Changes of inflammatory indicators after surgery
Pre- vs. post-operative blood leukocyte counts and neutrophil-ratio difference
Time frame: Hour 3 after the surgery
Changes in renal bleeding after surgery
Pre- vs. post-operative difference in hemoglobin and hematocrit values
Time frame: Hour 3 after the surgery
Changes of renal-function after surgery
Preoperative and postoperative blood creatinine difference
Time frame: 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.
Time frame: Hour 3 after the surgery
Incidence of pneumothorax and hydrothorax
The rate of pneumothorax and hydrothorax after surgery
Time frame: Day 2 after the surgery
Incidence of ureteral stone street
The rate of ureteral stone street after surgery
Time frame: Day 2 after the surgery
Duration of operation
From the completion of anesthesia to the end of the suture incision.
Time frame: during the procedure
Duration of hospital stay
From the date of admission to the date of discharge.
Time frame: immediately after the discharge
Hospital costs
The cost from hospitalization to discharge.
Time frame: 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%).
Time frame: Day 2 after the surgery
Plan to share: Yes — All individual participant data that underlie results in a publication.
Supporting information: Study protocol, Informed consent form
Time frame: Starting 1 year after publication.
Access criteria: When proper editing or review requirements are met, the study data will be available from the study manager after the study is completed.
Started Oct 2022 (actual). Primary completion is estimated for Dec 2024, 26 months after the start.
Of 31 interventional studies with no phase under Urinary Calculi, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 79. This study's planned 26 months is below that.
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The First Affiliated Hospital of University of South China