UrolithiasisNCT06624306
Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position for Percutaneous Nephrolithotomy (PCNL)
A study testing Prone PNL and Prone-flexed PNL in people with Urolithiasis and Kidney Stone, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Kidney Stone, Complication
- What is being tested?
- Prone PNL and Prone-flexed PNL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Staghorn calculi
- Renal pelvis stones \>2 cm
- Lower pole stones \>1.5 cm
- SWL-resistant stones
Who cannot join
- Age \<18 years or Pregnancy
- Bilateral simultaneous PCNL
- Need for 3 percutaneous tracts intraoperative
- Morbid obesity (BMI \>40)
- Non opaque renal stones.
- Refuse to complete study requirements
- Atypical bowel interposition need CT guided puncture
- Tumour in the presumptive access tract area or Potential malignant kidney tumour
Trial locations and contacts
1 site in 1 country.
About this study
Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)
- Conditions
- Urolithiasis, Kidney Stone, Complication
- Being tested
- Prone PNL, Prone-flexed PNL
- Medical subject headings
- Urolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone PNLProcedure or surgery
Prone PNL
Prone-flexed PNLProcedure or surgery
Prone-flexed PNL
| Study group | Role | What they receive |
|---|---|---|
| prone PNL | Active comparator | Prone PNL Receives: Procedure: Prone PNL |
| prone-flexed PNL | Active comparator | prone-flexed PNL Receives: Procedure: Prone-flexed PNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the prone with the prone-flexed position for PCNL reporting complications
Outcome measures by using the clavien dindo classification system
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Dec 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Abdel Azim El Helaly, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624306
- Sponsor's protocol ID
- PF-PCNL
- Status last verified
- Dec 2023
- First submitted
- 24 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position for Percutaneous Nephrolithotomy (PCNL)
- ClinicalTrials.gov ID
- NCT06624306
- Acronym / sponsor ID
- PF-PCNL
- Conditions
- Urolithiasis, Kidney Stone, Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prone PNL | Active comparator | Procedure: Prone PNLProne PNL |
| prone-flexed PNL | Active comparator | Procedure: Prone-flexed PNLprone-flexed PNL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Staghorn calculi
- Renal pelvis stones \>2 cm
- Lower pole stones \>1.5 cm
- SWL-resistant stones
Key exclusion criteria (8 listed)
- Age \<18 years or Pregnancy
- Bilateral simultaneous PCNL
- Need for 3 percutaneous tracts intraoperative
- Morbid obesity (BMI \>40)
- Non opaque renal stones.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone PNLProne PNL | Procedure or surgery | prone PNL |
| Prone-flexed PNLProne-flexed PNL | Procedure or surgery | prone-flexed PNL |
Primary outcome
Comparing the prone with the prone-flexed position for PCNL reporting complications
Time frame: 1 year
Outcome measures by using the clavien dindo classification system
1 secondary outcome
Assessment of stone free rate of the two groups
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone PNL and Prone-flexed PNL in people with Urolithiasis and Kidney Stone, run by Fayoum University Hospital 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 4 inclusion and 8 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 2 Oct 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the prone with the prone-flexed position for PCNL reporting complications (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2024; AzTrials last refreshed its copy on 27 Oct 2026.