Clinical trial NCT05578807: Total Tubeless Percutaneous Nephrolithotomy Without a Ureteral Catheter
Official title: A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Total Tubeless 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: 2022-10-13
Enrollment: 100
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: Total tubeless Percutaneous nephrolithotomy (PCNL) is a modified surgical method of PCNL surgery, that is, there is no indwelling nephrostomy tube and double-J tube during PCNL surgery. Compared with traditional PCNL surgery, it has the advantages of reducing pain, shortening operation time and reducing operation cost. Since this procedure was first performed in 2004, several randomized clinical studies have verified the safety and efficacy of total tubeless PCNL. Conventional total tubeless 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, a large number of literature reports and the surgical experience of PCNL in the past 20 years tell the investigators that the reverse insertion of ureteral catheter can cause many recent surgical complications.The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the total tubular PCNL surgery.

Detailed description: The purpose of this single-center, single-blind, randomized trial was to investigate whether without retrograde insertion of a ureteral catheter is appropriate for total tubeless percutaneous nephrolithotomy. It is planned to start in October 2022 and is expected to end in October 2024. Based on inclusion and exclusion criteria, 100 subjects were expected to be recruited. In a parallel group design, subjects were randomly assigned to two groups: the experimental group received total tubeless PCNL without reverse insertion of a ureteral catheter , and the control group received conventional total tubeless 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 kidney stones who met the indications for PCNL surgery.
* the maximum diameter of calculi was less than 35 mm.
* the width of hydronephrosis effusion was less than 25mm.

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: