Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones

Completed

• Conditions: Stone;Renal

• Registration Number: NCT03932370
• Lead Sponsor: Assiut University

Brief Summary

Management of nephrolithiasis is evolving rapidly, and various minimally-invasive urological procedures are currently available for treating patients with renal stones, including extracorporeal shockwave lithotripsy (ESWL), flexible ureteroscopy (f-URS) and miniaturised percutaneous nephrolithotomy (mini-PCNL).

Despite being the only truly-non-invasive, outpatient procedure, stone-free rates (SFRs) of ESWL are lower than both mini-PCNL and f-URS. Furthermore, ESWL has several limitations, such as pregnancy; uncorrected coagulopathy;aortic aneurism; severe obesity; large stone burdens (\>2cm); stones with high densities (\>970/1000 Hounsfield units); ESWL-resistant stone compositions; lower calyceal stones with unfavourable anatomical criteria; and stones in calyceal diverticula; Morbidities of the conventional PCNL are significantly minimised by using less access diameters in PCNL while providing comparable SFRs. Additionally, Mini and Micro PCNL result in shorter hospital stay and higher tubeless rates compared to conventional PCNL.

Flexible ureteroscopy has been increasingly used as a primary modality for treatment of renal stones with significantly lower complication rates than PCNL and mini-PCNL in terms of less bleeding and transfusion rates, shorter hospital stay and less postoperative pain. Additionally, f-URS is the only treatment modality of nephrolithiasis that can be safely and effectively used in patients with bleeding tendency, as well as pregnant women; moreover, its outcomes are not affected by obesity. Nevertheless, its poor durability and high costs remain major limitations for f-URS, especially in developing countries.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-27
• Study First Submitted QC: 2019-04-27
• Study First Posted: 2019-04-30
• Study Start: 2019-05-27
• Primary Completion: 2021-07-30
• Study Completion: 2021-12-27
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-24
• Last Update Posted: 2025-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Age above than 15 years
• Renal stone(s) with total burden of 2 cm or less
• Signature on written, informed consents with the details of this study requirements.
• Inappropriateness or failure of ESWL (examples of ESWL inappropriateness: patient preference; distal obstruction; contraindications of ESWL)

Exclusion Criteria

• Uncorrectable bleeding diathesis
• Current pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
initial stone clearance	24 hours after the operation	Number of participants who has been totally cleared of stones as measured by KUB and ultrasound
final stone clearance	90 days after the operation	Number of participants who has been totally cleared of stones as measured by non-contrast CT

Secondary Outcome Measures

Name	Time	Method
Haemoglobin drop	within 24 hours	The percentage of haemoglobin drop before and after the operation
Operative time	Within 24 hours	time passed during the operation
Hospital stay	Within a week from the operation	Number of days the patient has been hospitalised

Trial Locations

Locations (1)

Assiut Urology and Nephrology Hospital; 🇪🇬 Asyut, Asyut Governorate, Egypt