Comparison of the Efficacy of Flexible Ureteroscope and Percutaneous Nephroscopic Surgery in the Treatment of 2-4cm Kidney Stones
- Conditions
- Kidney Stone
- Interventions
- Procedure: percutaneous nephrolithotomyProcedure: flexible ureteroscopic lithotripsy
- Registration Number
- NCT06507176
- Lead Sponsor
- The First Hospital of Jilin University
- Brief Summary
Urolithiasis is a common disease in urology. With the continuous progress of science and technology, the treatment of kidney lithiasis has undergone revolutionary changes, and the previously commonly used open surgical lithotomy method has been gradually eliminated, and replaced with less traumatic treatment methods. Percutaneous nephroscopy can theoretically treat the vast majority of kidney stones, especially in the treatment of kidney stones \> 2 cm, it is widely used. With the development of ureteroscopy technology, the adaptation of ureteroscopy for the treatment of kidney stones has been expanding, and people have gradually paid attention to it with less damage and higher safety. This study aims to evaluate whether the efficacy and safety of soft ureteral lithotomy in the treatment of 2-4cm kidney stones is equal to that of percutaneous nephrolithotomy through prospective randomized controlled clinical trials, so as to provide more choices for physicians and patients, and provide theoretical basis for the standardization of clinical practice and the rationality of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 224
- The patient agrees to participate in the experiment and signs the informed consent, including compliance with the requirements of the experiment
- American Society of Anesthesiologists (ASA) score of 1-2, tolerate surgery
- Age 18-70 years old
- Diagnosed with renal stones via CT scan, with the largest diameter of the stone being 2-4 cm.
- Excessive obesity, BMI > 28
- Severe urinary tract infection not corrected
- Previous history of kidney transplantation or urinary tract diversion surgery
- Uncorrected bleeding or patients with coagulation dysfunction
- Urinary system congenital malformations, such as polycystic kidney, horseshoe kidney, pelvic ectopic kidney, etc
- Combined with serious heart and lung dysfunction and failure of important organs and cannot tolerate anesthesia or surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description percutaneous nephrolithotomy percutaneous nephrolithotomy - flexible ureteroscopic lithotripsy flexible ureteroscopic lithotripsy -
- Primary Outcome Measures
Name Time Method Stone free-rate (SFR) All patients underwent a 2mm plain CT scan 1 month after surgery to assess final SFR. Stone-free status is defined as the absence of any residual stone fragments or the presence of clinically meaningless residual stone fragments in the kidney, defined as ≤4mm, asymptomatic, non-obstructive, and non-infectious stone particles.
- Secondary Outcome Measures
Name Time Method Time of operation From transurethral surgery to indwelling fistula or catheter, assessed up to 6 hours. Time of operation：From transurethral surgery to indwelling fistula or catheter.
Length of stay From leaving the operating room to discharge,assessed up to 1 month. Length of stay: from leaving the operating room to discharge
Postoperative complication Any surgery-related adverse events that occurred during or less than one month after surgery. Postoperative complication：Any surgery-related adverse events that occurred during or less than one month after surgery
Hospitalization costs From admission to discharge,assessed up to 1 month. Hospitalization costs: Total costs during hospitalization
Trial Locations
- Locations (1)
Yanbowang
🇨🇳Ch'ang-ch'un, Jilin, China