Percutaneous Nephrolithotomy Without a Ureteral Catheter

The First Affiliated Hospital of University of South China

Status

Enrolling

Conditions

Nephrolithotomy Percutaneous

Kidney Calculi

Treatments

Procedure: PCNL without reverse insertion of a ureteral catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT05598671

nhfy0520

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.