Clinical trial NCT06507176: Comparison of the Efficacy of Flexible Ureteroscope and Percutaneous Nephroscopic Surgery in the Treatment of 2-4cm Kidney Stones
Official title: Comparison of the Efficacy of Flexible Ureteroscope and Percutaneous Nephroscopic Surgery in the Treatment of 2-4cm Kidney Stones: a Multicenter Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Stone
Keywords: kidney stone
flexible ureteroscope
percutaneous nephroscopic surgery
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stone free-rate (SFR)
timeFrame: All patients underwent a 2mm plain CT scan 1 month after surgery to assess final SFR.
Secondary outcomes:
measure: Time of operation
timeFrame: From transurethral surgery to indwelling fistula or catheter, assessed up to 6 hours.
measure: Length of stay
timeFrame: From leaving the operating room to discharge,assessed up to 1 month.
measure: Postoperative complication
timeFrame: Any surgery-related adverse events that occurred during or less than one month after surgery.
measure: Hospitalization costs
timeFrame: From admission to discharge,assessed up to 1 month.
Other outcomes:
Locations:
city: Ch'ang-ch'un
country: China
facility: Yanbowang
state: Jilin
Study officials:
References: