Supine Percutaneous Nephrolithotomy

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Stone
• Intervention / Treatment: Procedure: percutaneous nephrolithotomy (supine position); Procedure: percutaneous nephrolithotomy ( prone position)

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11367
    • Ain Shams University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: supine percutaneous nephrolithotomy; percutaneous nephrolithotomy to be done in the supine position	Procedure: percutaneous nephrolithotomy (supine position); percutaneous nephrolithotomy to be done in the supine position
Active Comparator: prone percutaneous nephrolithotomy; percutaneous nephrolithotomy to be done in the prone position	Procedure: percutaneous nephrolithotomy ( prone position); percutaneous nephrolithotomy in the prone position

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: March 6, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: R32/ 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No