Supine Percutaneous Nephrolithotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Renal Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

percutaneous nephrolithotomy to be performed in both supine and prone position

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

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supine percutaneous nephrolithotomy

percutaneous nephrolithotomy to be done in the supine position

Group Type EXPERIMENTAL

percutaneous nephrolithotomy (supine position)

Intervention Type PROCEDURE

percutaneous nephrolithotomy to be done in the supine position

prone percutaneous nephrolithotomy

percutaneous nephrolithotomy to be done in the prone position

Group Type ACTIVE_COMPARATOR

percutaneous nephrolithotomy ( prone position)

Intervention Type PROCEDURE

percutaneous nephrolithotomy in the prone position

Interventions

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percutaneous nephrolithotomy (supine position)

percutaneous nephrolithotomy to be done in the supine position

Intervention Type PROCEDURE

percutaneous nephrolithotomy ( prone position)

percutaneous nephrolithotomy in the prone position

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No