A Phase 2/3 interventional study of percutaneous nephrolithotomy (supine position) and percutaneous nephrolithotomy ( prone position) in Renal Stone, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2022-07-14.
Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment
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.
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.
598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.
This study's enrollment of 70 is below the median of 90 across 461 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
percutaneous nephrolithotomy to be done in the supine position
Procedure: percutaneous nephrolithotomy (supine position)
percutaneous nephrolithotomy to be done in the prone position
Procedure: percutaneous nephrolithotomy ( prone position)
percutaneous nephrolithotomy to be done in the supine position
percutaneous nephrolithotomy in the prone position
stone free rate
evaluation of our patients after surgery with Xray or CT to detect residual stones
Time frame: first day postoperative
Fluoroscopy time during the procedure in minutes
time of fluoroscopy exposure in minutes intraoperative, time of radiational exposure during the surgery. operative finding only
Time frame: intraoperative finding in minutes,
operative time of the procedure in minutes
time from patient positioning till the end of the procedure, operative finding only
Time frame: intraoperative finding in minutes,
rate of Hemoglobin drop
change in the perioperative hemoglobin level
Time frame: day 1 post operative
hospital stay
days of hospital stay after the surgery
Time frame: first 2 days post surgery
incidence of urinary tract infection
presence of manifested urinary tract infection in our patient
Time frame: first 7 days post surgery
urine leakage
urine leakage from the percutaneous renal tract
Time frame: first 3 days postoperative
irrigation fluid usage
amount of irrigation fluid used during the surgery in liters
Time frame: intraoperative finding
postoperative fever
incidence of postoperative fever more than 38 c
Time frame: first 2 days post surgery
need for DJ application
the need for DJ application intraoperative due to rough manipulation, bleeding or residual stones
Time frame: intraoperative finding
incidence of intraoperative colonic injury
the accident injury to adjacent colon
Time frame: intraoperative finding
Plan to share: No
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Ain Shams University