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AzTrials

UrolithiasisNCT06012864

Supine Versus Prone PNL in Pediatric

A study testing PNL in people with Urolithiasis, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages Up to 18 yearsHealthy volunteers can take part
Conditions the study is for
Urolithiasis
What is being tested?
PNL
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
30 Aug 2023to 30 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

mostafa kamel, A L contact

01061133200

mostafa075@aun.edu.eg

Egypt1 site

  • Assiut University Hospital

    Asyut, 11751

    mostafa kamel, A L, 01061133200, mostafa075@aun.edu.eg

Other trials in Egypt

About this study

Official title: Modified Flank-free Supine Versus Prone PNL in Pediatric Renal Stones: A Prospective Randomized Comparative Trial

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

Read the detailed description

Incidence of pediatric urolithiasis varies from 5%-15% in developing countries to 1%-5% in the developed ones. The 5-year recurrence rate of about55% (range, 38%-70%). Fernstrom and Johansson first introduced percutaneous nephrolithotomy (PNL) in 1976. Since that PNL has become widely used for multiple indications. Pediatric PNL was done in the prone position with more rapid and easy puncture point determination, wider field for renal puncture, free application of multiple accesses, and avoidance of visceral injuries, especially the colon. PNL in the supine position has several advantages as, similar success rate and a shorter operative time than conventional PNL. The Amplatz sheath is oriented downward, maintaining a low pressure in the renal pelvis and reducing the fluid absorption with rapid drainage of the fragmented stones. Furthermore, it's easier for the anesthesiologist to control the airway and reduce the neural and ophthalmologic pressure lesions than the prone position. Desoky et al in 2012 described the flank-free modified supine position (FFMSP) and claimed that this position overcomes the mechanical limitation of ordinary supine position because of ample space for puncture, dilatation, multiple tracts, and maneuverability of the system with the nephoscope. Moreover, the surgeon can comfortably sit during the operation, and X-ray exposure is reduced because puncture and dilatation are quite perpendicular to the body, and the operator's hands are outside the fluoroscopic field. it's better to do supine PNL in case of retro renal colon. as we see the supine position in pediatric is still under research and few trials about it had been done with no clear recommendation, so we will compare PNL in pediatric age group in modified free flank supine position versus prone position.

Conditions
Urolithiasis
Being tested
PNL
Medical subject headings
Urolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PNLProcedure or surgery

    percutaneous extraction of the stones in the kidney

Study groups in NCT06012864
Study groupRoleWhat they receive
modified supine PNLExperimentalpatients doing FFMS PNL
Receives: Procedure: PNL
prone PNLExperimentalpatients doing prone PNL
Receives: Procedure: PNL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sucess rate

    stone free rate

    Measured: within 3 months post operative

Secondary outcomes (2)

  1. complication rate

    rate of patients develop complication

    Measured: 1 month

  2. operative time

    from the puncture untill the end

    Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2023
  2. Study start30 Aug 2023 (estimated)
  3. Primary completion30 Aug 2025 (estimated)
  4. Study completion30 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients divided into two groups (group A: modified supine PNL, group B: prone PNL)
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06012864
Sponsor's protocol ID
Supine pediatric PNL
Status last verified
Aug 2023
First submitted
22 Aug 2023
Last updated
28 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 14751372

  • 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.

    PubMed 24050895

  • 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.

    PubMed 20218888

  • 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.

    PubMed 25217714

  • 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.

    PubMed 34861776

  • 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.

    PubMed 19046091

  • 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.

    PubMed 23373958

  • 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.

    PubMed 12042103

  • 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.

    PubMed 26558017

  • 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.

    PubMed 18262711

  • 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.

    PubMed 35985922

Questions about this trial

What is this clinical trial studying?

A study testing PNL in people with Urolithiasis, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact mostafa kamel, A L (01061133200, mostafa075@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sucess rate (time frame: within 3 months post operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06012864, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.

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