to Study the Role of Retrograde Intrarenal Surgery in Management of Renal Stones

Not Applicable

Recruiting

• Conditions: Retrograde Intrarenal Surgery In Management Of Renal Stones

• Registration Number: NCT05648877
• Lead Sponsor: Menoufia University

Brief Summary

Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience

Detailed Description

With the advancements in endourologic technology, in the last 30 years, renal stone treatment has dramatically changed, and minimally invasive treatments options, such as extracorporeal shock wave lithotripsy (SWL), percutaneous nephrolithotomy (PCNL), mini-PCNL, retrograde intrarenal surgery (RIRS) or laparoscopy, have replaced open surgery.

Although, minimally invasive treatment modalities have an excellent stone fragmentation rate, the clearance of stone fragments may not be immediate and can occur for any time after the intervention.

The European Association of Urology (EAU) guidelines, recommends PCNL for renal stones greater than 2 cm, and SWL is suggested primarily for stones less than 1 cm in size. Although SWL, RIRS and PCNL are all presented as treatment options for renal stones between, which application is a matter of preference.

The treatment modality selection of renal stones usually depends on stone-related factors (location, size, and composition), clinical factors (patient's comorbidities, patient's compliance, solitary kidney, and abnormal anatomy), and technical factors (equipment available for treatment, success rates, possible complications, invasiveness, the need for anesthetics, hospitalization times, and costs).

PCNL can achieve better results but is more invasive, is associated with greater morbidity and complications, and may be reserved for selected circumstances.

Stone clearance following kidney stone treatment is not well defined. For lower pole stones, Sener and colleagues compared RIRS with SWL and reported a stone-free rate of 52.3% with patients treated using RIRS one week after treatment. However after three months, the stone-free rate improved to 100%.

Ureteroscopic lithotripsy has been the most widely applied treatment for urinary tract stones, with high success and low complication rates. The holmium laser has facilitated the disintegration of stones and increased the effectiveness of ureteroscopic lithotripsy.

Improvements in the new generation of flexible ureteroscopes have made retrograde endoscopic ureteroscopy and laser lithotripsy for renal calculi more popular. The overall success rates of retrograde intrarenal surgery have been reported as 75% to 95% for intrarenal stones \> 2 cm after the first or second treatment, whereas the major and minor complication rates vary from 1.5% to 12%, which are less frequent than rates in PCNL procedures.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-13
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-14
• Last Update Posted: 2023-01-18
• Primary Completion: 2023-02-25
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• All patients with renal stones were eligible for the procedure. Patients with difficult PCNL

Exclusion Criteria

• Uncorrected coagulopathy Distal obstruction Active urinary tract infection Ureteropelvic junction obstruction Congenital renal anomalies Staghorn stones

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
stone free rates and complications	Up to 6 months	Stone free rates of both semirigid and flexible URS

Trial Locations

Locations (1)

Menoufia faculty of medicine; 🇪🇬 Shibin-al-Kawm, Al-Minufiyah, Egypt