Assiut Urology and Nephrology Hospital
Asyut, Asyut Governorate, 71515, Egypt
NCT Number: NCT03932370
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.
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Notify Me16 year–90 year
All sexes
Observational
Asyut, Asyut Governorate, 71515, Egypt
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: RIRS, f.URS, Retrograde Intrarenal Surgery
The procedure is done in the prone position under fluoroscopy guidance with a semi-rigid 12Fr. Nephroscope
Other names: Mini-perc, Mini-PCNL, m.PCNL
Time frame: 24 hours after the operation
Number of participants who has been totally cleared of stones as measured by KUB and ultrasound
Time frame: 90 days after the operation
Number of participants who has been totally cleared of stones as measured by non-contrast CT
Time frame: Within 24 hours
time passed during the operation
Time frame: Within a week from the operation
Number of days the patient has been hospitalised
Time frame: within 24 hours
The percentage of haemoglobin drop before and after the operation
Assiut University
Other
Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones 2 Cm or Less; A Randomised, Comparative Study.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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