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Completed

NCT Number: NCT04869969

Supine Percutaneous Nephrolithotomy

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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Key information

Conditions

Renal Stone Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University hospital

Cairo, 11367, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

percutaneous nephrolithotomy (supine position)

Procedure

percutaneous nephrolithotomy to be done in the supine position

percutaneous nephrolithotomy ( prone position)

Procedure

percutaneous nephrolithotomy in the prone position

Primary outcomes

  1. stone free rate

    Time frame: first day postoperative

    evaluation of our patients after surgery with Xray or CT to detect residual stones

Secondary outcomes

  1. Fluoroscopy time during the procedure in minutes

    Time frame: intraoperative finding in minutes,

    time of fluoroscopy exposure in minutes intraoperative, time of radiational exposure during the surgery. operative finding only

  2. operative time of the procedure in minutes

    Time frame: intraoperative finding in minutes,

    time from patient positioning till the end of the procedure, operative finding only

  3. rate of Hemoglobin drop

    Time frame: day 1 post operative

    change in the perioperative hemoglobin level

  4. hospital stay

    Time frame: first 2 days post surgery

    days of hospital stay after the surgery

  5. incidence of urinary tract infection

    Time frame: first 7 days post surgery

    presence of manifested urinary tract infection in our patient

  6. urine leakage

    Time frame: first 3 days postoperative

    urine leakage from the percutaneous renal tract

  7. irrigation fluid usage

    Time frame: intraoperative finding

    amount of irrigation fluid used during the surgery in liters

  8. postoperative fever

    Time frame: first 2 days post surgery

    incidence of postoperative fever more than 38 c

  9. need for DJ application

    Time frame: intraoperative finding

    the need for DJ application intraoperative due to rough manipulation, bleeding or residual stones

  10. incidence of intraoperative colonic injury

    Time frame: intraoperative finding

    the accident injury to adjacent colon

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 3, 2021
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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