Supine Percutaneous Nephrolithotomy

Renal Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04869969
• Other study ID #: R32/ 2019
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 30, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Renal Stone

Intervention

Procedure:
• percutaneous nephrolithotomy (supine position)
percutaneous nephrolithotomy to be done in the supine position
• percutaneous nephrolithotomy ( prone position)
percutaneous nephrolithotomy in the prone position

Locations

Country	Name	City	State
Egypt	Ain Shams University hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stone free rate	evaluation of our patients after surgery with Xray or CT to detect residual stones	first day postoperative
Secondary	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,
Secondary	operative time of the procedure in minutes	time from patient positioning till the end of the procedure, operative finding only	intraoperative finding in minutes,
Secondary	rate of Hemoglobin drop	change in the perioperative hemoglobin level	day 1 post operative
Secondary	hospital stay	days of hospital stay after the surgery	first 2 days post surgery
Secondary	incidence of urinary tract infection	presence of manifested urinary tract infection in our patient	first 7 days post surgery
Secondary	urine leakage	urine leakage from the percutaneous renal tract	first 3 days postoperative
Secondary	irrigation fluid usage	amount of irrigation fluid used during the surgery in liters	intraoperative finding
Secondary	postoperative fever	incidence of postoperative fever more than 38 c	first 2 days post surgery
Secondary	need for DJ application	the need for DJ application intraoperative due to rough manipulation, bleeding or residual stones	intraoperative finding
Secondary	incidence of intraoperative colonic injury	the accident injury to adjacent colon	intraoperative finding