An interventional study of PCNL without reverse insertion of a ureteral catheter in Nephrolithotomy Percutaneous and Kidney Calculi, 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 2024-02-28.
Sponsored by The First Affiliated Hospital of University of South China · Not applicable, Interventional, and Treatment
Conventional Percutaneous nephrolithotomy (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, repeated operation on the ureter can bring about immediate and long-term negative effects, such as ureteral false way formation, ureteral damage, perforation, avulsion, catheter insertion into the vena cava, pricking the kidney, increased postoperative pain, urinary extravasation, scar formation, and ureteral narrowing. The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the PCNL surgery.
The purpose of this single-center, single-blind, randomized trial was to evaluate the safety and efficacy of PCNL without reverse insertion of a ureteral catheter. It is planned to start in November 2022 and is expected to end in November 2024. Based on inclusion and exclusion criteria, 200 subjects were expected to be recruited. In a parallel group design, subjects were randomly assigned to two groups: the experimental group received PCNL without reverse insertion of a ureteral catheter , and the control group received traditional 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.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 200 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney 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.
Percutaneous nephrolithotomy without reverse insertion of a ureteral catheter
Procedure: PCNL without reverse insertion of a ureteral catheter
Percutaneous nephrolithotomy with reverse insertion of a ureteral catheter
The ureteral catheter was not retrograde inserted during PCNL
Rate of fever
Fever was defined as axillary temperature greater than 38.5 ° C.
Time frame: 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 postoperative
Time frame: Day 2 before surgery、hour 3 after the surgery
Neutrophils granulocyte change value
The change value of Neutrophils granulocyte between preoperative and postoperative
Time frame: Day 2 before surgery、hour 3 after the surgery
Hemoglobin change value
The change value of Hemoglobin between preoperative and postoperative
Time frame: Day 2 before surgery、hour 3 after the surgery
Hematocrit change value
The change value of Hematocrit between preoperative and postoperative
Time frame: Day 2 before surgery、hour 3 after the surgery
Rate of renal subcapsular hematoma
The proportion of postoperative renal subcapsular hematoma in all patients
Time frame: Day 2 after the surgery
Serum creatinine change value
The change value of Serum creatinine between preoperative and postoperative
Time frame: 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.
Time frame: Hour 2 after the surgery
Rate of hydrothorax
Hydrothorax appeared on the surgical side.
Time frame: Day 2 after the surgery
Stone free rate
Residual stone less than 4mm in diameter was considered to have been cleared.
Time frame: 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
Time frame: During the procedure
length of hospital stay
Length of hospital stay indicated the number of days between the operation date and discharge date
Time frame: 2 weeks after surgery
Medical costs
All medical expenses incurred to treat stones.
Time frame: 2 weeks after surgery
Plan to share: Yes — Individual participant data will be made available to other researchers after the study Report are published.
Supporting information: Study protocol, Informed consent form
Time frame: One year after the study report was published,but the duration is uncertain.
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.
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The First Affiliated Hospital of University of South China