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

Sponsor

Menoufia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05648877

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Retrograde Intrarenal Surgery In Management Of Renal Stones	Device: Ureteroscope	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

77 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Feb 25, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 43 semirigid ureteropyeloscopy 43 Patients underwent semirigid ureteropyeloscopy	Device: Ureteroscope Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience
Active Comparator: 34 flexible ureteropyeloscopy 34 patients with flexible ureteropyeloscopy	Device: Ureteroscope Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience

Arm

Intervention/Treatment

Experimental: 43 semirigid ureteropyeloscopy

43 Patients underwent semirigid ureteropyeloscopy

Device: Ureteroscope

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

Active Comparator: 34 flexible ureteropyeloscopy

34 patients with flexible ureteropyeloscopy

Device: Ureteroscope

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

Outcome Measures

Primary Outcome Measures

stone free rates and complications [Up to 6 months]
Stone free rates of both semirigid and flexible URS

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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