F-URS and Mini PCNL for Pediatric Urolithiasis

NCT06571617 | Not Yet Recruiting

• 1 other identifier: 22.08.684
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

To compare RIRS versus mini-perc PNL in the management of medium size pediatric renal stones (10-20 mm) through a RCT.

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (1)

• the primary outcome, the stone-free rate

  no evidence of any residual fragment by NCCT or KUB or clinical insignificant residual fragments (CIRF) ≤ 4 mm in maximum diameter in a single session within the first month postoperatively.

  at 4 weeks postoperatively

Secondary Outcomes (1)

• The Secondary outcomes, perioperative parameters

  intraoperative and first day postoperatively

Other Outcomes (1)

• the tertiary outcome. post operative pain score

  at first day post operative

Study Arms (2)

Mini PCNL (mini percutaneous nephrolithotomy)

ACTIVE COMPARATOR

Under general anesthesia, a 5/ 6 Fr ureteric catheter will be placed in the pelvicalyceal system. then the patient is turned to the prone position. A puncture will be done using an 18 G needle under fluoroscopy guidance. The tract will be dilated up to 15 F and then a sheath will be placed. A 12 F nephoscope (MIP-M, Karl Storz Endoscopy, Tuttlingen, Germany) will be used. Stone fragmentation will be performed using holmium YAG Laser energy. Then, Fragments will be evacuated using vacuum cleaner effect, tipless basket, or 5 FR stone forceps for stone analysis. A nephrostomy tube 12 Fr will be fixed at the end of the procedure.

Procedure: Mini PCNL (mini percutaneous nephrolithotomy)

RIRS (retrograde intrarenal surgery/ flexible URS)

ACTIVE COMPARATOR

Under general anesthesia, the children will be placed in the lithotomy position . Cystoscopy or rigid ureteroscopy will be performed to place a hydrophilic guidewire to the renal pelvis under fluoroscopic guidance. After passing a 0.035/0.038-inch safety guidewire into the renal pelvis, a ureteral access sheath will be placed (9.5/11.5 Fr, 35 cm) will be used according to the surgeon preference. . RIRS will be performed using a single use digital Flexible ureteroscopy . A manual irrigation pump system will be used to hydro dilate the ureter during ureteroscopy. The stones will be fragmented with a holmium:YAG laser until they will be deemed small enough to pass spontaneously. Some residual fragments will be removed by tipless nitinol basket for stone analysis. A double-J stent OR URETERIC CATHETER will be placed at the end of the procedure based on surgeon's decision. .

Procedure: RIRS (retrograde intrarenal surgery/ flexible URS)

Interventions

Mini PCNL (mini percutaneous nephrolithotomy) PROCEDURE

half of the cases will be treated using mini PCNL

Mini PCNL (mini percutaneous nephrolithotomy)

RIRS (retrograde intrarenal surgery/ flexible URS) PROCEDURE

THE OTHER HALF WILL BE TRAETED USING Flexible URS

RIRS (retrograde intrarenal surgery/ flexible URS)

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 12 years or younger
• American society of anesthesia (ASA) score I or II.
• Renal stone measured between 10-20 mm.
• An informed consent obtained from their parents

You may not qualify if:

• Bleeding tendency
• Active urinary tract infection (UTI).
• Renal anatomical abnormalities (ectopic kidney, horseshoe kidney, ADPCK).
• Skeletal deformities
• Concomitant ureteric stone or stricture.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and nephrology center

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ramy F Elbaz

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramy F Elbaz

CONTACT

01092759184; ramifrag7@gmail.com

Ahmed Shoma

CONTACT

01223766818

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: Patients will be randomized using computer-generated random tables in a 1:1 ratio to be allocated to one of two groups, the first group will undergo mini-PNL, and the second group will undergo RIRS.

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: September 10, 2024
• Primary Completion: March 10, 2025
• Study Completion: April 5, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after 4 months for 6 months
• Access Criteria: via email: ramifrag7@gmail.com

Locations

EG (1)