Comparison of the Efficacy of Flexible Ureteroscope and Percutaneous Nephroscopic Surgery in the Treatment of 2-4cm Kidney Stones

Jilin University

Status: Enrolling

Conditions: Kidney Stone

Treatments: Procedure: flexible ureteroscopic lithotripsy; Procedure: percutaneous nephrolithotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06507176

yanbo wang

Details and patient eligibility

About

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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient agrees to participate in the experiment and signs the informed consent, including compliance with the requirements of the experiment
2. American Society of Anesthesiologists (ASA) score of 1-2, tolerate surgery
3. Age 18-70 years old
4. Diagnosed with renal stones via CT scan, with the largest diameter of the stone being 2-4 cm.

Exclusion criteria

1. Excessive obesity, BMI > 28
2. Severe urinary tract infection not corrected
3. Previous history of kidney transplantation or urinary tract diversion surgery
4. Uncorrected bleeding or patients with coagulation dysfunction
5. Urinary system congenital malformations, such as polycystic kidney, horseshoe kidney, pelvic ectopic kidney, etc
6. Combined with serious heart and lung dysfunction and failure of important organs and cannot tolerate anesthesia or surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 2 patient groups

flexible ureteroscopic lithotripsy

Experimental group

Treatment:

Procedure: flexible ureteroscopic lithotripsy

percutaneous nephrolithotomy

Active Comparator group

Treatment:

Procedure: percutaneous nephrolithotomy