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

NCT ID: NCT06507176

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-21
• Study Completion Date: 2026-11-15

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.

Conditions

Kidney Stone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

flexible ureteroscopic lithotripsy

Group Type: EXPERIMENTAL

flexible ureteroscopic lithotripsy

Intervention Type: PROCEDURE

This group of patients underwent flexible ureteroscopic lithotripsy.

percutaneous nephrolithotomy

Group Type: ACTIVE_COMPARATOR

percutaneous nephrolithotomy

Intervention Type: PROCEDURE

This group of patients underwent percutaneous nephrolithotomy.

Interventions

flexible ureteroscopic lithotripsy

This group of patients underwent flexible ureteroscopic lithotripsy.

Intervention Type: PROCEDURE

percutaneous nephrolithotomy

This group of patients underwent percutaneous nephrolithotomy.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Yanbo Wang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yanbowang

Ch’ang-ch’un, Jilin, China

Site Status: RECRUITING

Countries

China

Facility Contacts

yanbo wang, doctor

Role: primary

wangyanb@jlu.edu.cn

wangyanb@jlu.edu.cn

Other Identifiers

yanbo wang

Identifier Type: -

Identifier Source: org_study_id