Supine Versus Prone PNL in Pediatric

Not Applicable

Not yet recruiting

• Conditions: Urolithiasis
• Interventions: Procedure: PNL

• Registration Number: NCT06012864
• Lead Sponsor: Assiut University

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, it's 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 operator's hands are outside the fluoroscopic field. it's 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 Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-08-22
• Last Update Submitted: 2023-08-22
• Study First Posted: 2023-08-28
• Last Update Posted: 2023-08-28
• Study Start: 2023-08-30
• Primary Completion: 2025-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Age ≤ 18 years old. Renal stones are amenable for PNL with Guy's stone score 1-2.

Exclusion Criteria

congenital anomalies. skeletal anomalies. bleeding diathesis. active urinary tract infection. Patient refusing participation. Patients with PCN.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
modified supine PNL	PNL	patients doing FFMS PNL
prone PNL	PNL	patients doing prone PNL

Primary Outcome Measures

Name	Time	Method
sucess rate	within 3 months post operative	stone free rate

Secondary Outcome Measures

Name	Time	Method
complication rate	1 month	rate of patients develop complication
operative time	intraoperative	from the puncture untill the end

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt