Kidney Calculi, Nephrolithiasis, Urolithiasis
Conditions
Keywords
Urolithiasis, Kidney Calculi, RIRS, UAS, Suction UAS, Endourology, Laser Lithotripsy, Stone-Free Rate
Brief summary
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.
Interventions
PROCEDURERetrograde intrarenal surgery using a ureteral access sheath with suction
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.
PROCEDURERetrograde intrarenal surgery using a traditional ureteral access sheath
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two groups of participants were assigned in parallel. One group underwent retrograde intrarenal surgery using a ureteral access sheath with suction. The other group underwent retrograde intrarenal surgery using a traditional ureteral access sheath without suction. Both groups were followed to compare safety and effectiveness outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged eighteen years or older * Male or female participants * Presence of a single kidney stone measuring up to twenty millimeters * Candidate for retrograde intrarenal surgery according to clinical evaluation * Able and willing to provide informed consent
Exclusion criteria
* Active or untreated urinary infection * History of open kidney surgery or kidney trauma * Contraindications to anesthesia, including uncontrolled diabetes, severe cardiac disease, or significant coagulation disorders * Presence of ureteral narrowing or obstruction at the junction between the ureter and the kidney * Positive urine culture that does not resolve after appropriate treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-free rate | One month after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of surgery | During surgery | Total time required to complete the surgical procedure, measured from the insertion of the ureteroscope until placement of the ureteral stent. |
| Readmission after surgery | Within one month after surgery | Number of participants requiring hospital readmission for pain, infection, or any complication related to the surgery. |
| Need for an additional procedure | Within three months after surgery | Proportion of participants requiring a second surgical intervention to remove remaining stone material. |
| Urinary infection after surgery | Within one month after surgery | Occurrence of laboratory-confirmed urinary infection requiring medical treatment, classified using the Clavien-Dindo system. |
| Systemic infection after surgery | Within one month after surgery | Occurrence of systemic infection requiring medical intervention, including antibiotic therapy or hospitalization, assessed using the Clavien-Dindo classification. |
Countries
Egypt
Outcome results
None listed