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

NCT06507176 | Recruiting

• 1 other identifier: yanbo wang
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Keywords

kidney stone; flexible ureteroscope; percutaneous nephroscopic surgery

Outcome Measures

Primary Outcomes (1)

• Stone free-rate (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.

  All patients underwent a 2mm plain CT scan 1 month after surgery to assess final SFR.

Secondary Outcomes (4)

• Time of operation

  From transurethral surgery to indwelling fistula or catheter, assessed up to 6 hours.

• Length of stay

  From leaving the operating room to discharge,assessed up to 1 month.

• 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.

Study Arms (2)

flexible ureteroscopic lithotripsy

EXPERIMENTAL

Procedure: flexible ureteroscopic lithotripsy

percutaneous nephrolithotomy

ACTIVE COMPARATOR

Procedure: percutaneous nephrolithotomy

Interventions

flexible ureteroscopic lithotripsy PROCEDURE

This group of patients underwent flexible ureteroscopic lithotripsy.

flexible ureteroscopic lithotripsy

percutaneous nephrolithotomy PROCEDURE

This group of patients underwent percutaneous nephrolithotomy.

percutaneous nephrolithotomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

Yanbowang

Ch’ang-ch’un, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 18, 2024
• Study Start: July 21, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication

Locations

CN (1)