Ignite Creation Date:
2024-05-06 @ 1:06 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03932370
Status:
UNKNOWN
Last Update Posted:
2019-04-30
First Post:
2019-04-27
Brief Title:
Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones 2 Cm or Less A Randomised Comparative Study
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 coagulopathyaortic aneurism severe obesity large stone burdens 2cm stones with high densities 9701000 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
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 coagulopathyaortic aneurism severe obesity large stone burdens 2cm stones with high densities 9701000 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None