Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones
NCT ID: NCT03932370
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
118 participants
OBSERVATIONAL
2019-05-27
2021-12-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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f-URS
Flexible ureteroscopy
The procedure will be performed in an endourology room where a radiolucent operative table together with a C-arm, a video-camera unit and a Laser device are available. Irrigation fluids include normal saline and/or sterile water.
mini-PCNL
mini-Percutaneus nephrolithotomy
The procedure is done in the prone position under fluoroscopy guidance with a semi-rigid 12Fr. Nephroscope
Interventions
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Flexible ureteroscopy
The procedure will be performed in an endourology room where a radiolucent operative table together with a C-arm, a video-camera unit and a Laser device are available. Irrigation fluids include normal saline and/or sterile water.
mini-Percutaneus nephrolithotomy
The procedure is done in the prone position under fluoroscopy guidance with a semi-rigid 12Fr. Nephroscope
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Current pregnancy
16 Years
90 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Amr Esam Saad Mohamed Darwish
assistant lecturer of urology
Locations
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Assiut Urology and Nephrology Hospital
Asyut, Asyut Governorate, Egypt
Countries
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Other Identifiers
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NCT03932370
Identifier Type: -
Identifier Source: org_study_id
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