Clinical trial NCT05598671: Percutaneous Nephrolithotomy Without a Ureteral Catheter
Official title: A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nephrolithotomy Percutaneous
Kidney Calculi
Lead sponsor: The First Affiliated Hospital of University of South China
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

· Patients with upper urinary tract stones who were 18 years of age or older and eligible for PCNL surgery.

Exclusion Criteria:

* patients with infectious calculi confirmed by preoperative CT examination and blood biochemical indexes.
* Patients with severe cardiac and pulmonary insufficiency, coagulation dysfunction and other obvious surgical contraindications.
* Patients with previous history of PCNL surgery on the affected side or nephrotomy.
* Patients with indwelling double J tube or nephrostomy tube before operation.
* Patients with renal trauma or congenital anomalies of urinary system.

Primary outcomes:
measure: Rate of fever
timeFrame: From the day of surgery to the day of discharge, up to 2 weeks.
measure: White blood cell count change value
timeFrame: Day 2 before surgery、hour 3 after the surgery
measure: Neutrophils granulocyte change value
timeFrame: Day 2 before surgery、hour 3 after the surgery
measure: Hemoglobin change value
timeFrame: Day 2 before surgery、hour 3 after the surgery
measure: Hematocrit change value
timeFrame: Day 2 before surgery、hour 3 after the surgery
measure: Rate of renal subcapsular hematoma
timeFrame: Day 2 after the surgery
measure: Serum creatinine change value
timeFrame: Day 2 before surgery、Hour 3 after the surgery
measure: visual analog scale (VAS)pain score
timeFrame: Hour 2 after the surgery
measure: Rate of hydrothorax
timeFrame: Day 2 after the surgery
Secondary outcomes:
measure: Stone free rate
timeFrame: Day 2 after the surgery
measure: Operation time
timeFrame: During the procedure
measure: length of hospital stay
timeFrame: 2 weeks after surgery
measure: Medical costs
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
Study officials:
affiliation: the First Affiliated Hospital of the University of South China
name: Mingyong Li, MD.
role: STUDY_DIRECTOR
References: