Supine Percutaneous Nephrolithotomy
Primary Purpose
Renal Stone
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
percutaneous nephrolithotomy (supine position)
percutaneous nephrolithotomy ( prone position)
Sponsored by
About this trial
This is an interventional treatment trial for Renal Stone
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
Sites / Locations
- Ain Shams University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
supine percutaneous nephrolithotomy
prone percutaneous nephrolithotomy
Arm Description
percutaneous nephrolithotomy to be done in the supine position
percutaneous nephrolithotomy to be done in the prone position
Outcomes
Primary Outcome Measures
stone free rate
evaluation of our patients after surgery with Xray or CT to detect residual stones
Secondary Outcome Measures
Fluoroscopy time during the procedure 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 minutes
time from patient positioning till the end of the procedure, operative finding only
rate of Hemoglobin drop
change in the perioperative hemoglobin level
hospital stay
days of hospital stay after the surgery
incidence of urinary tract infection
presence of manifested urinary tract infection in our patient
urine leakage
urine leakage from the percutaneous renal tract
irrigation fluid usage
amount of irrigation fluid used during the surgery in liters
postoperative fever
incidence of postoperative fever more than 38 c
need for DJ application
the need for DJ application intraoperative due to rough manipulation, bleeding or residual stones
incidence of intraoperative colonic injury
the accident injury to adjacent colon
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04869969
Brief Title
Supine Percutaneous Nephrolithotomy
Official Title
Supine Versus Prone Percutaneous Nephrolithotomy in the Pediatric Age Group? A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
percutaneous nephrolithotomy to be performed in both supine and prone position
Masking
ParticipantOutcomes Assessor
Masking Description
patients and the statistician were blinded to the type of the intervention
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
supine percutaneous nephrolithotomy
Arm Type
Experimental
Arm Description
percutaneous nephrolithotomy to be done in the supine position
Arm Title
prone percutaneous nephrolithotomy
Arm Type
Active Comparator
Arm Description
percutaneous nephrolithotomy to be done in the prone position
Intervention Type
Procedure
Intervention Name(s)
percutaneous nephrolithotomy (supine position)
Intervention Description
percutaneous nephrolithotomy to be done in the supine position
Intervention Type
Procedure
Intervention Name(s)
percutaneous nephrolithotomy ( prone position)
Intervention Description
percutaneous nephrolithotomy in the prone position
Primary Outcome Measure Information:
Title
stone free rate
Description
evaluation of our patients after surgery with Xray or CT to detect residual stones
Time Frame
first day postoperative
Secondary Outcome Measure Information:
Title
Fluoroscopy time during the procedure in minutes
Description
time of fluoroscopy exposure in minutes intraoperative, time of radiational exposure during the surgery. operative finding only
Time Frame
intraoperative finding in minutes,
Title
operative time of the procedure in minutes
Description
time from patient positioning till the end of the procedure, operative finding only
Time Frame
intraoperative finding in minutes,
Title
rate of Hemoglobin drop
Description
change in the perioperative hemoglobin level
Time Frame
day 1 post operative
Title
hospital stay
Description
days of hospital stay after the surgery
Time Frame
first 2 days post surgery
Title
incidence of urinary tract infection
Description
presence of manifested urinary tract infection in our patient
Time Frame
first 7 days post surgery
Title
urine leakage
Description
urine leakage from the percutaneous renal tract
Time Frame
first 3 days postoperative
Title
irrigation fluid usage
Description
amount of irrigation fluid used during the surgery in liters
Time Frame
intraoperative finding
Title
postoperative fever
Description
incidence of postoperative fever more than 38 c
Time Frame
first 2 days post surgery
Title
need for DJ application
Description
the need for DJ application intraoperative due to rough manipulation, bleeding or residual stones
Time Frame
intraoperative finding
Title
incidence of intraoperative colonic injury
Description
the accident injury to adjacent colon
Time Frame
intraoperative finding
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ain Shams University hospital
City
Cairo
ZIP/Postal Code
11367
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Supine Percutaneous Nephrolithotomy
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