Supine Percutaneous Nephrolithotomy

Phase 2

Completed

• Conditions: Renal Stone
• Interventions: Procedure: percutaneous nephrolithotomy (supine position); Procedure: percutaneous nephrolithotomy ( prone position)

• Registration Number: NCT04869969
• Lead Sponsor: Ain Shams University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2021-01-01
• Study First Submitted: 2021-03-06
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-03
• Study Completion: 2021-09-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• patients aged from two to sixteen years old with single or multiple renal stones indicated for percutaneous nephrolithotomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supine percutaneous nephrolithotomy	percutaneous nephrolithotomy (supine position)	percutaneous nephrolithotomy to be done in the supine position
prone percutaneous nephrolithotomy	percutaneous nephrolithotomy ( prone position)	percutaneous nephrolithotomy to be done in the prone position

Primary Outcome Measures

Name	Time	Method
stone free rate	first day postoperative	evaluation of our patients after surgery with Xray or CT to detect residual stones

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ain Shams University hospital; 🇪🇬 Cairo, Egypt