Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06031103
Status:
COMPLETED
Last Update Posted:
2023-09-11
First Post:
2023-08-19
Brief Title:
Clinical Efficacy of Mini-PCNLversus RIRS for the Management of Upper Urinary Tract Calculus 1-25 cm
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Clinical Efficacy of Mini-Percutaneous Nephrolithotomy Versus Retrograde Intrarenal Surgery for the Management of Upper Urinary Tract Calculus 1-25 cm in Children 10 Years of Age
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
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:
The goal of this type of studyprospective randomized clinical trial The main question is to compare the outcomes of mini-percutaneous nephrolithotomy m-PCNL and retrograde intrarenal surgery RIRS in treating upper urinary tract calculus in children 10 years
Detailed Description:
With the increase in morbidity and incidence of pediatric kidney stone disease childhood urolithiasis has become a significant health problem worldwide especially in developing countries Children with urinary calculi are at high risk for recurrent stone formation and may require multiple surgical interventions
In recent decades with the improvement of miniaturization of surgical equipment the management of pediatric kidney stone disease has changed dramatically As a result of these improvements minimally invasive techniques such as percutaneous nephrolithotomy PCNL and retrograde intrarenal surgery RIRS are alternative treatment options for children with upper urinary tract calculus
Extracorporeal shock wave lithotripsy ESWL has been used for the treatment of upper urinary tract calculus 2 cm but The significantly lower stone-free rates SFR of SWL as compared to the PCNL and RIRS requirement for anesthesia the possibility of parenchymal damage to the growing kidney and the need for additional sessions are the significant limitations of SWL
Mini-percutaneous nephrolithotomy Mini-PCNL is an adjustment of the standard PCNL procedure after the development of small-caliber instruments that has several advantages such as a smaller skin incision smaller tract size and less bleeding However mini-PCNL may cause severe complications because of fragile parenchyma small caliber collecting system and mobile kidney in pediatric patients
with the persistent advancement of endoscopic instruments and flexible ureteroscope the examination of the upper urinary tract has become more feasible and retrograde intrarenal surgery RIRS can effectively compete with PCNL However the outcomes of the use of flexible ureteroscope in the pediatric population such as the risk of ureteral injury stone-free rate especially in large stones more than 2 cm need for the ancillary procedure the need to indwell double-J stent in advance and high cost of instrument and maintenance remain largely unknown resulting in controversy about the clinical safety and efficacy of PCNL and RIRS in the treatment of upper urinary tract calculus
In the current study the investigators aimed to compare RIRS and mini-PCNL by evaluating The operative and postoperative outcomes for children 10 years of age with upper urinary tract calculus 1-25 cm
In recent decades with the improvement of miniaturization of surgical equipment the management of pediatric kidney stone disease has changed dramatically As a result of these improvements minimally invasive techniques such as percutaneous nephrolithotomy PCNL and retrograde intrarenal surgery RIRS are alternative treatment options for children with upper urinary tract calculus
Extracorporeal shock wave lithotripsy ESWL has been used for the treatment of upper urinary tract calculus 2 cm but The significantly lower stone-free rates SFR of SWL as compared to the PCNL and RIRS requirement for anesthesia the possibility of parenchymal damage to the growing kidney and the need for additional sessions are the significant limitations of SWL
Mini-percutaneous nephrolithotomy Mini-PCNL is an adjustment of the standard PCNL procedure after the development of small-caliber instruments that has several advantages such as a smaller skin incision smaller tract size and less bleeding However mini-PCNL may cause severe complications because of fragile parenchyma small caliber collecting system and mobile kidney in pediatric patients
with the persistent advancement of endoscopic instruments and flexible ureteroscope the examination of the upper urinary tract has become more feasible and retrograde intrarenal surgery RIRS can effectively compete with PCNL However the outcomes of the use of flexible ureteroscope in the pediatric population such as the risk of ureteral injury stone-free rate especially in large stones more than 2 cm need for the ancillary procedure the need to indwell double-J stent in advance and high cost of instrument and maintenance remain largely unknown resulting in controversy about the clinical safety and efficacy of PCNL and RIRS in the treatment of upper urinary tract calculus
In the current study the investigators aimed to compare RIRS and mini-PCNL by evaluating The operative and postoperative outcomes for children 10 years of age with upper urinary tract calculus 1-25 cm
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