Supine Versus Prone PNL in Pediatric

NCT ID: NCT06012864

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2026-08-30

Brief Summary

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

modified supine PNL

patients doing FFMS PNL

Group Type: EXPERIMENTAL

PNL

Intervention Type: PROCEDURE

percutaneous extraction of the stones in the kidney

prone PNL

patients doing prone PNL

Group Type: EXPERIMENTAL

PNL

Intervention Type: PROCEDURE

percutaneous extraction of the stones in the kidney

Interventions

PNL

percutaneous extraction of the stones in the kidney

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Kamel Abdel Rahman

DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Eltaher, MD

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut University Hospital

Asyut, , Egypt

Countries

Egypt

Central Contacts

mostafa kamel, A L

Role: CONTACT

mostafa075@aun.edu.eg

01061133200

Facility Contacts

mostafa kamel, A L

Role: primary

mostafa075@aun.edu.eg

01061133200

References

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Reference Type: BACKGROUND

PMID: 14751372 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24050895 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 25217714 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 26558017 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18262711 (View on PubMed)

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.

Reference Type: BACKGROUND

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Other Identifiers

Supine pediatric PNL

Identifier Type: -

Identifier Source: org_study_id