Supine Versus Prone PNL in Pediatric

NCT06012864 | Not Yet Recruiting DMC

• 1 other identifier: Supine pediatric PNL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To Compare the safety and efficacy of PNL in a modified flank-free supine position versus prone position in pediatric patients

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (1)

• sucess rate

  stone free rate

  within 3 months post operative

Secondary Outcomes (2)

• complication rate

  1 month

• operative time

  intraoperative

Study Arms (2)

modified supine PNL

EXPERIMENTAL

patients doing FFMS PNL

Procedure: PNL

prone PNL

EXPERIMENTAL

patients doing prone PNL

Procedure: PNL

Interventions

PNL PROCEDURE

percutaneous extraction of the stones in the kidney

modified supine PNL; prone PNL

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age ≤ 18 years old. Renal stones are amenable for PNL with Guy's stone score 1-2.

You may not qualify if:

• congenital anomalies. skeletal anomalies. bleeding diathesis. active urinary tract infection. Patient refusing participation. Patients with PCN.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 11751, Egypt

Location

Related Publications (11)

• 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.

  PMID: 14751372 BACKGROUND

• 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.

  PMID: 24050895 BACKGROUND

• 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.

  PMID: 20218888 BACKGROUND

• 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.

  PMID: 25217714 BACKGROUND

• 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.

  PMID: 34861776 BACKGROUND

• 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.

  PMID: 19046091 BACKGROUND

• 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.

  PMID: 23373958 BACKGROUND

• 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.

  PMID: 12042103 BACKGROUND

• 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.

  PMID: 26558017 BACKGROUND

• 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.

  PMID: 18262711 BACKGROUND

• 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.

  PMID: 35985922 BACKGROUND

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

• Ahmed Eltaher, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

mostafa kamel, A L

CONTACT

01061133200; mostafa075@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: closed envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Model Details: Patients divided into two groups (group A: modified supine PNL, group B: prone PNL)

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: August 30, 2023
• Primary Completion: August 30, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)