Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06012864
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-28
First Post:
2023-08-22
Brief Title:
Supine Versus Prone PNL in Pediatric
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Modified Flank-free Supine Versus Prone PNL in Pediatric Renal Stones A Prospective Randomized Comparative Trial
Status:
NOT_YET_RECRUITING
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:
To Compare the safety and efficacy of PNL in a modified flank-free supine position versus prone position in pediatric patients
Detailed Description:
Incidence of pediatric urolithiasis varies from 5-15 in developing countries to 1-5 in the developed ones The 5-year recurrence rate of about55 range 38-70 Fernstrom and Johansson first introduced percutaneous nephrolithotomy PNL in 1976 Since that PNL has become widely used for multiple indications Pediatric PNL was done in the prone position with more rapid and easy puncture point determination wider field for renal puncture free application of multiple accesses and avoidance of visceral injuries especially the colon PNL in the supine position has several advantages as similar success rate and a shorter operative time than conventional PNL The Amplatz sheath is oriented downward maintaining a low pressure in the renal pelvis and reducing the fluid absorption with rapid drainage of the fragmented stones Furthermore its easier for the anesthesiologist to control the airway and reduce the neural and ophthalmologic pressure lesions than the prone position Desoky et al in 2012 described the flank-free modified supine position FFMSP and claimed that this position overcomes the mechanical limitation of ordinary supine position because of ample space for puncture dilatation multiple tracts and maneuverability of the system with the nephoscope Moreover the surgeon can comfortably sit during the operation and X-ray exposure is reduced because puncture and dilatation are quite perpendicular to the body and the operators hands are outside the fluoroscopic field its better to do supine PNL in case of retro renal colon as we see the supine position in pediatric is still under research and few trials about it had been done with no clear recommendation so we will compare PNL in pediatric age group in modified free flank supine position versus prone position
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