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Clinical Efficacy of Mini-PCNLversus RIRS for the Management of Upper Urinary Tract Calculus (1-2.5 cm)

Primary Purpose

Stone, Kidney

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mini-PCNL procedure
RIRS procedure
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stone, Kidney focused on measuring Pediatric stones, retrograde intrarenal surgery, mini-per-cutaneous nephrostomy

Eligibility Criteria

1 Month - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: This study will include all children (age < 10 years) who undergo Mini-PCNL or RIRS with stone size (1_2.5 cm) for upper urinary tract stones Exclusion Criteria: Children with urinary tract infections until treated Children with ureteral stricture Congenital urological anomalies Previous urological surgery

Sites / Locations

  • Abdelrahman Nazmy Abbas Hatata

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

childhood urolithiasis treated with mini PCNL Procedure

childhood urolithiasis treated with RIRS Procedure

Arm Description

pediatric patients with upper urinary tract calculus treated with mini-PCNL procedure

pediatric patients with upper urinary tract calculus treated with mini-PCNL procedure

Outcomes

Primary Outcome Measures

The fluoroscopy time of mini-PCNL and RIRS procedures in both groups
the duration of fluoroscopy time measured by seconds that the patient is exposed to during the procedure in both groups
the stone free rate in both groups
Procedures will be accepted as stone free when there are no residual fragments or stone fragments <3 mm at follow-up CTUT
The operation time of mini-PCNL and RIRS procedures in both groups
the time of procedure measured by minutes in both groups
postoperative hospital stay time of mini-PCNL and RIRS procedures in both groups
the post operative hospital stay measured by hours

Secondary Outcome Measures

Full Information

First Posted
August 19, 2023
Last Updated
September 2, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT06031103
Brief Title
Clinical Efficacy of Mini-PCNLversus RIRS for the Management of Upper Urinary Tract Calculus (1-2.5 cm)
Official Title
Clinical Efficacy of Mini-Percutaneous Nephrolithotomy Versus Retrograde Intrarenal Surgery for the Management of Upper Urinary Tract Calculus (1-2.5 cm) in Children ≤10 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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

5. Study Description

Brief Summary
The goal of this [ type of study:]prospective randomized clinical trial. The main question is to compare the outcomes of mini-percutaneous nephrolithotomy (m-PCNL) and retrograde intrarenal surgery (RIRS) in treating upper urinary tract calculus in children ≤ 10 years.
Detailed Description
With the increase in morbidity and incidence of pediatric kidney stone disease, childhood urolithiasis has become a significant health problem worldwide, especially in developing countries. Children with urinary calculi are at high risk for recurrent stone formation and may require multiple surgical interventions. In recent decades, with the improvement of miniaturization of surgical equipment, the management of pediatric kidney stone disease has changed dramatically. As a result of these improvements, minimally invasive techniques, such as percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS) are alternative treatment options for children with upper urinary tract calculus. Extracorporeal shock wave lithotripsy (ESWL) has been used for the treatment of upper urinary tract calculus < 2 cm. but, The significantly lower stone-free rates (SFR) of SWL as compared to the PCNL and RIRS, requirement for anesthesia, the possibility of parenchymal damage to the growing kidney and the need for additional sessions are the significant limitations of SWL Mini-percutaneous nephrolithotomy (Mini-PCNL) is an adjustment of the standard PCNL procedure after the development of small-caliber instruments that has several advantages such as a smaller skin incision, smaller tract size, and less bleeding. However, mini-PCNL may cause severe complications because of fragile parenchyma, small caliber collecting system, and mobile kidney in pediatric patients. with the persistent advancement of endoscopic instruments and flexible ureteroscope, the examination of the upper urinary tract has become more feasible, and retrograde intrarenal surgery (RIRS) can effectively compete with PCNL. However, the outcomes of the use of flexible ureteroscope in the pediatric population such as the risk of ureteral injury, stone-free rate especially in large stones (more than 2 cm), need for the ancillary procedure, the need to indwell double-J stent in advance and high cost of instrument and maintenance remain largely unknown, resulting in controversy about the clinical safety and efficacy of PCNL and RIRS in the treatment of upper urinary tract calculus. In the current study, the investigators aimed to compare RIRS and mini-PCNL by evaluating The operative and postoperative outcomes for children ≤10 years of age with upper urinary tract calculus (1-2.5 cm).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stone, Kidney
Keywords
Pediatric stones, retrograde intrarenal surgery, mini-per-cutaneous nephrostomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
childhood urolithiasis treated with mini PCNL Procedure
Arm Type
Active Comparator
Arm Description
pediatric patients with upper urinary tract calculus treated with mini-PCNL procedure
Arm Title
childhood urolithiasis treated with RIRS Procedure
Arm Type
Active Comparator
Arm Description
pediatric patients with upper urinary tract calculus treated with mini-PCNL procedure
Intervention Type
Procedure
Intervention Name(s)
mini-PCNL procedure
Intervention Description
Mini-PCNL . A 12 Fr rigid nephroscope and a Holmium:YAG laser as energy source was used for surgery Percutaneous renal puncture was achieved with an 18 Ga needle after displaying renal collecting system with contrast material. and tract dilatation was achieved using Amplatz dilators up to 16-18 Fr according to patient age
Intervention Type
Procedure
Intervention Name(s)
RIRS procedure
Intervention Description
RIRS Technique the 9.5 Fr ureteral access sheath (UAS). UAS was inserted over the guide wire under fluoroscopy control. A flexible ureteroscope was passed through the UAS. If the UAS did not pass over the guide wire, the investigator moved the flexible ureteroscopy over the guide wire without access sheat
Primary Outcome Measure Information:
Title
The fluoroscopy time of mini-PCNL and RIRS procedures in both groups
Description
the duration of fluoroscopy time measured by seconds that the patient is exposed to during the procedure in both groups
Time Frame
for each case in both groups the investigator assess the duration of fluoroscopy that the patient is exposed during the time of operation which range from (2-4 hours) through study completion, an average of 1.5 year"
Title
the stone free rate in both groups
Description
Procedures will be accepted as stone free when there are no residual fragments or stone fragments <3 mm at follow-up CTUT
Time Frame
after one month from intervention
Title
The operation time of mini-PCNL and RIRS procedures in both groups
Description
the time of procedure measured by minutes in both groups
Time Frame
for each case in both groups the investigator assess the time of operation from the induction of anesthesia till the end of operation "through study completion, an average of 1.5 year"
Title
postoperative hospital stay time of mini-PCNL and RIRS procedures in both groups
Description
the post operative hospital stay measured by hours
Time Frame
or each case in both groups the investigator assess the hospital time from the day of admission of patient in hospital to do intervention till patient discharge from hospital through study completion, an average of 1.5 year"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: This study will include all children (age < 10 years) who undergo Mini-PCNL or RIRS with stone size (1_2.5 cm) for upper urinary tract stones Exclusion Criteria: Children with urinary tract infections until treated Children with ureteral stricture Congenital urological anomalies Previous urological surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed sa salem, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Abdelrahman Nazmy Abbas Hatata
City
Cairo
ZIP/Postal Code
11511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29069011
Citation
Lu P, Song R, Yu Y, Yang J, Qi K, Tao R, Chen K, Zhang W, Gu M. Clinical efficacy of percutaneous nephrolithotomy versus retrograde intrarenal surgery for pediatric kidney urolithiasis: A PRISMA-compliant article. Medicine (Baltimore). 2017 Oct;96(43):e8346. doi: 10.1097/MD.0000000000008346.
Results Reference
background
PubMed Identifier
22258667
Citation
Bastug F, Gunduz Z, Tulpar S, Poyrazoglu H, Dusunsel R. Urolithiasis in infants: evaluation of risk factors. World J Urol. 2013 Oct;31(5):1117-22. doi: 10.1007/s00345-012-0828-y. Epub 2012 Jan 19.
Results Reference
background
PubMed Identifier
32257806
Citation
Gao X, Fang Z, Lu C, Shen R, Dong H, Sun Y. Management of staghorn stones in special situations. Asian J Urol. 2020 Apr;7(2):130-138. doi: 10.1016/j.ajur.2019.12.014. Epub 2019 Dec 30.
Results Reference
background

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Clinical Efficacy of Mini-PCNLversus RIRS for the Management of Upper Urinary Tract Calculus (1-2.5 cm)

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