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Active, not recruitingNCT06624306Updated Oct 2, 2024

Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position for Percutaneous Nephrolithotomy (PCNL)

An interventional study of Prone PNL and Prone-flexed PNL in Urolithiasis, Kidney Stone and Complication, sponsored by Fayoum University Hospital. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by Fayoum University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as active, not recruiting.
  • Registered 9 months after the study started (first participant enrolled Dec 2023, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)

02

Conditions studied

  • Urolithiasis
  • Kidney Stone
  • Complication
03

In context

Kidney Calculi

598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.

This study's planned enrollment of 85 is close to the median of 90 across 461 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Fayoum University Hospital is the lead sponsor of 73 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Staghorn calculi
  2. Renal pelvis stones >2 cm
  3. Lower pole stones >1.5 cm
  4. SWL-resistant stones

Exclusion criteria

Exclusion Criteria:

  1. Age \<18 years or Pregnancy
  2. Bilateral simultaneous PCNL
  3. Need for 3 percutaneous tracts intraoperative
  4. Morbid obesity (BMI >40)
  5. Non opaque renal stones.
  6. Refuse to complete study requirements
  7. Atypical bowel interposition need CT guided puncture
  8. Tumour in the presumptive access tract area or Potential malignant kidney tumour
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
85 participants (estimated)

Study arms

  • Active comparator
    prone PNL

    Prone PNL

    Procedure: Prone PNL

  • Active comparator
    prone-flexed PNL

    prone-flexed PNL

    Procedure: Prone-flexed PNL

Interventions

  • ProcedureProne PNL

    Prone PNL

  • ProcedureProne-flexed PNL

    Prone-flexed PNL

06

What researchers measure

Primary outcomes

  1. Comparing the prone with the prone-flexed position for PCNL reporting complications

    Outcome measures by using the clavien dindo classification system

    Time frame: 1 year

Secondary outcomes

  1. Assessment of stone free rate of the two groups

    Outcome measures by stone fragment residual ≤ 2 mm by computed tomography (CT)

    Time frame: 1 year

07

Study locations

1 site
  • Fayoum faculty of Medicine
    Fayoum, 4558, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06624306
Lead sponsor
Fayoum University Hospital
Responsible party
Hesham Abdel Azim El Helaly (Assistant Professor, Fayoum University Hospital) — Principal investigator
First posted
Oct 2, 2024
Start date
Dec 1, 2023
Primary completion
Dec 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Oct 2, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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