Clinical trial NCT04869969: Supine Percutaneous Nephrolithotomy
Official title: Supine Versus Prone Percutaneous Nephrolithotomy in the Pediatric Age Group? A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Renal Stone
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: percutaneous nephrolithotomy to be performed in both supine and prone position
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: stone free rate
timeFrame: first day postoperative
Secondary outcomes:
measure: Fluoroscopy time during the procedure in minutes
timeFrame: intraoperative finding in minutes,
measure: operative time of the procedure in minutes
timeFrame: intraoperative finding in minutes,
measure: rate of Hemoglobin drop
timeFrame: day 1 post operative
measure: hospital stay
timeFrame: first 2 days post surgery
measure: incidence of urinary tract infection
timeFrame: first 7 days post surgery
measure: urine leakage
timeFrame: first 3 days postoperative
measure: irrigation fluid usage
timeFrame: intraoperative finding
measure: postoperative fever
timeFrame: first 2 days post surgery
measure: need for DJ application
timeFrame: intraoperative finding
measure: incidence of intraoperative colonic injury
timeFrame: intraoperative finding
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospital
Study officials:
References: