Supine Percutaneous Nephrolithotomy

Study Overview
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Brief Summary
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there is an increased incidence of renal stones, especially in the pediatric age group. the percutaneous approach in the pediatric age took a long time till it again accepted among surgeons worldwide. the prone position is the preferred approach to perform percutaneous nephrolithotomy in the pediatric age group. this study aims to compare supine versus prone position percutaneous nephrolithotomy in the pediatric age group.

Detailed Description
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The incidence of renal stones in the pediatric age group increased from 18.4 to 57.0% per100,000 children in the period from 1999 to 2008. The acceptance of PCNL in pediatrics was slow at first due to concerns of the small kidney size compared to relatively large instruments percutaneous nephrolithotomy in pediatric patients was conventionally performed in the prone position for historical reasons, being more familiar to surgeons and it was considered safer to avoid colonic injury. Supine PCNL has several valuable advantages to pediatric patients in particular better irrigation shorter operative time with a comparable outcome with the prone position. our study aims to assess the efficacy and the safety of percutaneous nephrolithotomy in the supine position in comparison to the prone position in the pediatric age group.

Official Title
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Supine Versus Prone Percutaneous Nephrolithotomy in the Pediatric Age Group? A Randomized Controlled Trial.

Conditions
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Renal Stone

Intervention / Treatment
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* Procedure: percutaneous nephrolithotomy (supine position)
* Procedure: percutaneous nephrolithotomy ( prone position)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged from two to sixteen years old with single or multiple renal stones indicated for percutaneous nephrolithotomy Exclusion Criteria: patients with renal anomalies, bleeding tendency, elevated kidney function tests for age, previous renal surgical intervention on the same site of intervention. patients with skeletal abnormalities and spine deformities were also excluded patients with a single kidney were also excluded

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: percutaneous nephrolithotomy to be performed in both supine and prone position
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: supine percutaneous nephrolithotomy<br>percutaneous nephrolithotomy to be done in the supine position | Procedure: percutaneous nephrolithotomy (supine position)<br>* percutaneous nephrolithotomy to be done in the supine position<br>|
| Active Comparator: prone percutaneous nephrolithotomy<br>percutaneous nephrolithotomy to be done in the prone position | Procedure: percutaneous nephrolithotomy ( prone position)<br>* percutaneous nephrolithotomy in the prone position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone free rate | evaluation of our patients after surgery with Xray or CT to detect residual stones | first day postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoroscopy time during the procedure in minutes | time of fluoroscopy exposure in minutes intraoperative, time of radiational exposure during the surgery. operative finding only | intraoperative finding in minutes, | 
| operative time of the procedure in minutes | time from patient positioning till the end of the procedure, operative finding only | intraoperative finding in minutes, | 
| rate of Hemoglobin drop | change in the perioperative hemoglobin level | day 1 post operative | 
| hospital stay | days of hospital stay after the surgery | first 2 days post surgery | 
| incidence of urinary tract infection | presence of manifested urinary tract infection in our patient | first 7 days post surgery | 
| urine leakage | urine leakage from the percutaneous renal tract | first 3 days postoperative | 
| irrigation fluid usage | amount of irrigation fluid used during the surgery in liters | intraoperative finding | 
| postoperative fever | incidence of postoperative fever more than 38 c | first 2 days post surgery | 
| need for DJ application | the need for DJ application intraoperative due to rough manipulation, bleeding or residual stones | intraoperative finding | 
| incidence of intraoperative colonic injury | the accident injury to adjacent colon | intraoperative finding |