Supine Versus Prone PNL in Pediatric
Primary Purpose
Urolithiasis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PNL
Sponsored by
About this trial
This is an interventional treatment trial for Urolithiasis
Eligibility Criteria
Inclusion Criteria: Age ≤ 18 years old. Renal stones are amenable for PNL with Guy's stone score 1-2. Exclusion Criteria: congenital anomalies. skeletal anomalies. bleeding diathesis. active urinary tract infection. Patient refusing participation. Patients with PCN.
Sites / Locations
- Assiut University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
modified supine PNL
prone PNL
Arm Description
patients doing FFMS PNL
patients doing prone PNL
Outcomes
Primary Outcome Measures
sucess rate
stone free rate
Secondary Outcome Measures
complication rate
rate of patients develop complication
operative time
from the puncture untill the end
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06012864
Brief Title
Supine Versus Prone PNL in Pediatric
Official Title
Modified Flank-free Supine Versus Prone PNL in Pediatric Renal Stones: A Prospective Randomized Comparative Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 30, 2023 (Anticipated)
Primary Completion Date
August 30, 2025 (Anticipated)
Study Completion Date
August 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
To Compare the safety and efficacy of PNL in a modified flank-free supine position versus prone position in pediatric patients
Detailed Description
Incidence of pediatric urolithiasis varies from 5%-15% in developing countries to 1%-5% in the developed ones. The 5-year recurrence rate of about55% (range, 38%-70%). Fernstrom and Johansson first introduced percutaneous nephrolithotomy (PNL) in 1976. Since that PNL has become widely used for multiple indications. Pediatric PNL was done in the prone position with more rapid and easy puncture point determination, wider field for renal puncture, free application of multiple accesses, and avoidance of visceral injuries, especially the colon. PNL in the supine position has several advantages as, similar success rate and a shorter operative time than conventional PNL. The Amplatz sheath is oriented downward, maintaining a low pressure in the renal pelvis and reducing the fluid absorption with rapid drainage of the fragmented stones. Furthermore, it's easier for the anesthesiologist to control the airway and reduce the neural and ophthalmologic pressure lesions than the prone position. Desoky et al in 2012 described the flank-free modified supine position (FFMSP) and claimed that this position overcomes the mechanical limitation of ordinary supine position because of ample space for puncture, dilatation, multiple tracts, and maneuverability of the system with the nephoscope. Moreover, the surgeon can comfortably sit during the operation, and X-ray exposure is reduced because puncture and dilatation are quite perpendicular to the body, and the operator's hands are outside the fluoroscopic field. it's better to do supine PNL in case of retro renal colon. as we see the supine position in pediatric is still under research and few trials about it had been done with no clear recommendation, so we will compare PNL in pediatric age group in modified free flank supine position versus prone position.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients divided into two groups (group A: modified supine PNL, group B: prone PNL)
Masking
Participant
Masking Description
closed envelope
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
modified supine PNL
Arm Type
Experimental
Arm Description
patients doing FFMS PNL
Arm Title
prone PNL
Arm Type
Experimental
Arm Description
patients doing prone PNL
Intervention Type
Procedure
Intervention Name(s)
PNL
Intervention Description
percutaneous extraction of the stones in the kidney
Primary Outcome Measure Information:
Title
sucess rate
Description
stone free rate
Time Frame
within 3 months post operative
Secondary Outcome Measure Information:
Title
complication rate
Description
rate of patients develop complication
Time Frame
1 month
Title
operative time
Description
from the puncture untill the end
Time Frame
intraoperative
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≤ 18 years old. Renal stones are amenable for PNL with Guy's stone score 1-2.
Exclusion Criteria:
congenital anomalies. skeletal anomalies. bleeding diathesis. active urinary tract infection. Patient refusing participation. Patients with PCN.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mostafa kamel, A L
Phone
01061133200
Email
mostafa075@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Eltaher, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
11751
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mostafa kamel, A L
Phone
01061133200
Email
mostafa075@aun.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
14751372
Citation
Holman E, Khan AM, Flasko T, Toth C, Salah MA. Endoscopic management of pediatric urolithiasis in a developing country. Urology. 2004 Jan;63(1):159-62; discussion 162. doi: 10.1016/j.urology.2003.08.043.
Results Reference
background
PubMed Identifier
24050895
Citation
Lao M, Kogan BA, White MD, Feustel PJ. High recurrence rate at 5-year followup in children after upper urinary tract stone surgery. J Urol. 2014 Feb;191(2):440-4. doi: 10.1016/j.juro.2013.09.021. Epub 2013 Sep 16.
Results Reference
background
PubMed Identifier
20218888
Citation
Liatsikos EN, Kallidonis P, Stolzenburg JU, Ost M, Keeley F, Traxer O, Bernardo N, Perimenis P, Smith AD. Percutaneous management of staghorn calculi in horseshoe kidneys: a multi-institutional experience. J Endourol. 2010 Apr;24(4):531-6. doi: 10.1089/end.2009.0264.
Results Reference
background
PubMed Identifier
25217714
Citation
Caione P, De Dominicis M, Collura G, Matarazzo E, Nappo SG, Capozza N. Microperc for pediatric nephrolithiasis: technique in valdivia-modified position. Eur J Pediatr Surg. 2015 Feb;25(1):94-9. doi: 10.1055/s-0034-1387939. Epub 2014 Sep 13.
Results Reference
background
PubMed Identifier
34861776
Citation
Desoky EAE, Sakr AM, ElSayed ER, Ali MM. Ultra-Mini-Percutaneous Nephrolithotomy in Flank-Free Modified Supine Position vs Prone Position in Treatment of Pediatric Renal Pelvic and Lower Caliceal Stones. J Endourol. 2022 May;36(5):610-614. doi: 10.1089/end.2021.0557. Epub 2022 Mar 9.
Results Reference
background
PubMed Identifier
19046091
Citation
Falahatkar S, Moghaddam AA, Salehi M, Nikpour S, Esmaili F, Khaki N. Complete supine percutaneous nephrolithotripsy comparison with the prone standard technique. J Endourol. 2008 Nov;22(11):2513-7. doi: 10.1089/end.2008.0463.
Results Reference
background
PubMed Identifier
23373958
Citation
Vicentini FC, Torricelli FC, Mazzucchi E, Hisano M, Murta CB, Danilovic A, Claro JF, Srougi M. Modified complete supine percutaneous nephrolithotomy: solving some problems. J Endourol. 2013 Jul;27(7):845-9. doi: 10.1089/end.2012.0725. Epub 2013 Jun 8.
Results Reference
background
PubMed Identifier
12042103
Citation
Kukreja RA, Desai MR, Sabnis RB, Patel SH. Fluid absorption during percutaneous nephrolithotomy: does it matter? J Endourol. 2002 May;16(4):221-4. doi: 10.1089/089277902753752160.
Results Reference
background
PubMed Identifier
26558017
Citation
Desoky EA, Allam MN, Ammar MK, Abdelwahab KM, Elsaid DA, Fawzi AM, Alayman AA, Shahin AM, Kamel HM. Flank free modified supine position: A new modification for supine percutaneous nephrolithotomy. Arab J Urol. 2012 Jun;10(2):143-8. doi: 10.1016/j.aju.2011.12.008. Epub 2012 Mar 7.
Results Reference
background
PubMed Identifier
18262711
Citation
De Sio M, Autorino R, Quarto G, Calabro F, Damiano R, Giugliano F, Mordente S, D'Armiento M. Modified supine versus prone position in percutaneous nephrolithotomy for renal stones treatable with a single percutaneous access: a prospective randomized trial. Eur Urol. 2008 Jul;54(1):196-202. doi: 10.1016/j.eururo.2008.01.067. Epub 2008 Feb 4.
Results Reference
background
PubMed Identifier
35985922
Citation
Emiliani E, Quiroz YY, Llorens E, Quintian C, Motta G, Villada D, Bujons A. Retrorenal colon in pediatric patients with urolithiasis: Is the supine position for PCNL advantageous? J Pediatr Urol. 2022 Dec;18(6):741.e1-741.e6. doi: 10.1016/j.jpurol.2022.07.028. Epub 2022 Aug 3.
Results Reference
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Supine Versus Prone PNL in Pediatric
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