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Supine Percutaneous Nephrolithotomy

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04869969
Enrollment
70
Registered
2021-05-03
Start date
2019-06-01
Completion date
2021-09-30
Last updated
2022-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Stone

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.

Interventions

PROCEDUREpercutaneous nephrolithotomy (supine position)

percutaneous nephrolithotomy to be done in the supine position

PROCEDUREpercutaneous nephrolithotomy ( prone position)

percutaneous nephrolithotomy in the prone position

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

patients and the statistician were blinded to the type of the intervention

Intervention model description

percutaneous nephrolithotomy to be performed in both supine and prone position

Eligibility

Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
stone free ratefirst day postoperativeevaluation of our patients after surgery with Xray or CT to detect residual stones

Secondary

MeasureTime frameDescription
urine leakagefirst 3 days postoperativeurine leakage from the percutaneous renal tract
irrigation fluid usageintraoperative findingamount of irrigation fluid used during the surgery in liters
postoperative feverfirst 2 days post surgeryincidence of postoperative fever more than 38 c
need for DJ applicationintraoperative findingthe need for DJ application intraoperative due to rough manipulation, bleeding or residual stones
incidence of urinary tract infectionfirst 7 days post surgerypresence of manifested urinary tract infection in our patient
Fluoroscopy time during the procedure in minutesintraoperative finding in minutes,time of fluoroscopy exposure in minutes intraoperative, time of radiational exposure during the surgery. operative finding only
operative time of the procedure in minutesintraoperative finding in minutes,time from patient positioning till the end of the procedure, operative finding only
rate of Hemoglobin dropday 1 post operativechange in the perioperative hemoglobin level
hospital stayfirst 2 days post surgerydays of hospital stay after the surgery
incidence of intraoperative colonic injuryintraoperative findingthe accident injury to adjacent colon

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026