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Supine Versus Prone PNL in Pediatric

Modified Flank-free Supine Versus Prone PNL in Pediatric Renal Stones: A Prospective Randomized Comparative Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06012864
Enrollment
100
Registered
2023-08-28
Start date
2023-08-30
Completion date
2026-08-30
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urolithiasis

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.

Interventions

PROCEDUREPNL

percutaneous extraction of the stones in the kidney

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

closed envelope

Intervention model description

Patients divided into two groups (group A: modified supine PNL, group B: prone PNL)

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
sucess ratewithin 3 months post operativestone free rate

Secondary

MeasureTime frameDescription
complication rate1 monthrate of patients develop complication
operative timeintraoperativefrom the puncture untill the end

Countries

Egypt

Contacts

Primary Contactmostafa kamel, A L
mostafa075@aun.edu.eg01061133200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026