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

NCT06031103 | Completed

• 1 other identifier: Pediatric renal stones
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stone, Kidney

Keywords

Pediatric stones; retrograde intrarenal surgery; mini-per-cutaneous nephrostomy

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  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"

Study Arms (2)

childhood urolithiasis treated with mini PCNL Procedure

ACTIVE COMPARATOR

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

Procedure: mini-PCNL procedure

childhood urolithiasis treated with RIRS Procedure

ACTIVE COMPARATOR

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

Procedure: RIRS procedure

Interventions

mini-PCNL procedure 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

childhood urolithiasis treated with mini PCNL Procedure

RIRS procedure 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

childhood urolithiasis treated with RIRS Procedure

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children with urinary tract infections until treated
• Children with ureteral stricture
• Congenital urological anomalies
• Previous urological surgery

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Abdelrahman Nazmy Abbas Hatata

Cairo, 11511, Egypt

Location

Related Publications (3)

• 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.

  PMID: 29069011 BACKGROUND

• 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.

  PMID: 22258667 BACKGROUND

• 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.

  PMID: 32257806 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• mohamed sa salem, MD

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2023
• First Posted: September 11, 2023
• Study Start: February 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)