This study compares two techniques used during RIRS for the treatment of kidney stones measuring up to 20 mm. During RIRS, surgeons often use a device called a UAS to help pass instruments into the urinary system and to assist with the removal of stone fragments. A traditional UAS allows irrigation fluid and small fragments to flow out passively. A newer type, known as a suction UAS, applies controlled negative pressure to help clear stone fragments more effectively and may reduce pressure inside the kidney during the procedure. The purpose of this study is to determine whether the suction UAS offers better clinical outcomes than the traditional UAS. The main outcomes assessed include the SFR, the duration of surgery, and complications after the procedure such as fever, sepsis, urinary infection, calyceal injury, or ureteral injury. In this randomized study, adult patients undergoing RIRS for a single renal stone were assigned to either the suction UAS or the traditional UAS. All patients were followed after surgery to assess stone clearance and any complications. The results of this study aim to provide evidence on whether suction UAS improves safety or effectiveness in RIRS compared with the traditional approach.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
This intervention involves performing retrograde intrarenal surgery using a ureteral access sheath equipped with a suction mechanism that applies controlled negative pressure to help remove stone fragments and manage pressure inside the kidney during the procedure.
This intervention involves performing retrograde intrarenal surgery using a conventional ureteral access sheath without suction, relying on irrigation flow and basket retrieval for stone fragment removal.
Ain Shams University Hospitals, Department of Urology
Cairo, Cairo Governorate, Egypt
Stone-free rate
The stone-free rate represents the proportion of participants who show no residual stone fragments or only clinically insignificant small fragments on postoperative imaging. Imaging is performed using non-contrast computed tomography. Findings are classified into four categories based on fragment size: complete clearance, fragments up to two millimeters, fragments between two point one and four millimeters, and fragments larger than four millimeters. The outcome is expressed as the percentage of participants achieving complete clearance or clinically insignificant fragments.
Time frame: One month after surgery
Duration of surgery
Total time required to complete the surgical procedure, measured from the insertion of the ureteroscope until placement of the ureteral stent.
Time frame: During surgery
Readmission after surgery
Number of participants requiring hospital readmission for pain, infection, or any complication related to the surgery.
Time frame: Within one month after surgery
Need for an additional procedure
Proportion of participants requiring a second surgical intervention to remove remaining stone material.
Time frame: Within three months after surgery
Urinary infection after surgery
Occurrence of laboratory-confirmed urinary infection requiring medical treatment, classified using the Clavien-Dindo system.
Time frame: Within one month after surgery
Systemic infection after surgery
Occurrence of systemic infection requiring medical intervention, including antibiotic therapy or hospitalization, assessed using the Clavien-Dindo classification.
Time frame: Within one month after surgery
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