Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06012864

Supine Versus Prone PNL in Pediatric

To Compare the safety and efficacy of PNL in a modified flank-free supine position versus prone position in pediatric patients

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PNL

Procedure

percutaneous extraction of the stones in the kidney

Primary outcomes

  1. sucess rate

    Time frame: within 3 months post operative

    stone free rate

Secondary outcomes

  1. complication rate

    Time frame: 1 month

    rate of patients develop complication

  2. operative time

    Time frame: intraoperative

    from the puncture untill the end

Study contacts

Contact information is provided by the study sponsor or research team.

mostafa kamel, A L

CONTACT

[email protected]

01061133200

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 28, 2023
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.