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

September 2, 2023 updated by: Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11511
        • Abdelrahman Nazmy Abbas Hatata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: childhood urolithiasis treated with mini PCNL Procedure
pediatric patients with upper urinary tract calculus treated with mini-PCNL procedure
Procedure: mini-PCNL procedure

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
Active Comparator: childhood urolithiasis treated with RIRS Procedure
pediatric patients with upper urinary tract calculus treated with mini-PCNL procedure
Procedure: RIRS procedure
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: mohamed sa salem, MD, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

August 19, 2023

First Submitted That Met QC Criteria

September 2, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pediatric renal stones

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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