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

NCT ID: NCT03932370

Last Updated: 2025-09-30

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-27

Study Completion Date

2021-12-27

Brief Summary

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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

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Conditions

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Stone;Renal

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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f-URS

Flexible ureteroscopy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

mini-Percutaneus nephrolithotomy

The procedure is done in the prone position under fluoroscopy guidance with a semi-rigid 12Fr. Nephroscope

Intervention Type PROCEDURE

Other Intervention Names

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RIRS f.URS Retrograde Intrarenal Surgery Mini-perc Mini-PCNL m.PCNL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amr Esam Saad Mohamed Darwish

assistant lecturer of urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut Urology and Nephrology Hospital

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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NCT03932370

Identifier Type: -

Identifier Source: org_study_id

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