Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones 2 Cm or Less; A Randomised, Comparative Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stone;Renal
- Sponsor
- Assiut University
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- initial stone clearance
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Amr Esam Saad Mohamed Darwish
assistant lecturer of urology
Assiut University
Eligibility Criteria
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
Outcomes
Primary Outcomes
initial stone clearance
Time Frame: 24 hours after the operation
Number of participants who has been totally cleared of stones as measured by KUB and ultrasound
final stone clearance
Time Frame: 90 days after the operation
Number of participants who has been totally cleared of stones as measured by non-contrast CT
Secondary Outcomes
- Haemoglobin drop(within 24 hours)
- Operative time(Within 24 hours)
- Hospital stay(Within a week from the operation)