Percutaneous Nephrolithotomy (PCNL)NCT03147950
Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)
A study testing Prone-Flexed PCNL and Prone PCNL in people with Percutaneous Nephrolithotomy (PCNL) and Prone Position, run by Mansoura University at 1 site in Egypt.
Trial summary
compare the prone with the prone-flexed position accessibility of upper and middle calyceal approach by subcostal puncture and PCNL reporting complications using the Clavien-Dindo system with Categorisation of PCNL-specific complications according to Clavien-Dindo classification score Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Nephrolithotomy (PCNL), Prone Position, Prone-Flexed Position
- What is being tested?
- Prone-Flexed PCNL and Prone PCNL
- 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
- 1 Jul 2017to 1 Jul 2018
- 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
- Large renal pelvic stone
- Upper calyceal stone
- Middle calyceal stone
Who cannot join
- lower calyceal stone
- Bilateral simultaneous PCNL
- Need for 3 percutaneous tracts intraoperative
- Morbid obesity (BMI >40)
- Non opaque renal stones.
- Refuse to complete study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL) Comparing Efficacy and Complication According to Clavien-Dindo Classification Score Randomised Controlled Study
compare the prone with the prone-flexed position accessibility of upper and middle calyceal approach by subcostal puncture and PCNL reporting complications using the Clavien-Dindo system with Categorisation of PCNL-specific complications according to Clavien-Dindo classification score
- Conditions
- Percutaneous Nephrolithotomy (PCNL), Prone Position, Prone-Flexed Position, Complication of Surgical Procedure
- Being tested
- Prone-Flexed PCNL, Prone PCNL
- Keywords
- Prone-Flexed Position, Percutaneous Nephrolithotomy (PCNL), Clavien-Dindo Classification Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone-Flexed PCNLProcedure or surgery
Also called Prone-Flexed Percutaneous Nephrolithotomy
Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)
Prone PCNLProcedure or surgery
Also called Prone Percutaneous Nephrolithotomy
Prone Position For Percutaneous Nephrolithotomy (PCNL)
| Study group | Role | What they receive |
|---|---|---|
| Prone-Flexed PCNL | Active comparator | Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL) Receives: Procedure: Prone-Flexed PCNL |
| Prone PCNL | Active comparator | Prone Position For Percutaneous Nephrolithotomy (PCNL) Receives: Procedure: Prone PCNL |
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 (2)
Assessment of stone free rate (SFR) of the two groups
Outcome measures by stone fragment residual ≤ 2 mm by computed tomography (CT)
Measured: 1 year
Asses the easiness of accessibility of the targeted stone
Outcome measures by counting number and site of puncture trial
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 posted10 May 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Nephrolithotomy (PCNL)Studies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelwahab Hashem, Mansoura University
- Investigators
- Ahmed Shoma, MD, Study chair, Urology and Nephrology centerAhmed Elassmy, MD, Study director, Urology and Nephrology centerNasr Eltabey, MD, Study director, Urology and Nephrology centerMohamed Zahran, MD, Principal investigator, Urology and Nephrology centerMahmoud Laimon, MSc, Principal investigator, Urology and Nephrology centerHossam Nabeeh, Msc, Principal investigator, Urology and Nephrology centerMohamed Abdulatif, Msc, Principal investigator, Urology and Nephrology center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147950
- Sponsor's protocol ID
- F-Prone PNL
- Status last verified
- May 2017
- First submitted
- 8 May 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: meta-analyses by contact the Prof. Ahmed Shoma, MD, Phd (Study Chair)
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL) Comparing Efficacy and Complication According to Clavien-Dindo Classification Score Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03147950
- Acronym / sponsor ID
- F-Prone PNL
- Conditions
- Percutaneous Nephrolithotomy (PCNL), Prone Position, Prone-Flexed Position, Complication of Surgical Procedure
- Keywords
- Prone-Flexed Position, Percutaneous Nephrolithotomy (PCNL), Clavien-Dindo Classification Score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 10 May 2017 (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.
compare the prone with the prone-flexed position accessibility of upper and middle calyceal approach by subcostal puncture and PCNL reporting complications using the Clavien-Dindo system with Categorisation of PCNL-specific complications according to Clavien-Dindo classification score
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone-Flexed PCNL | Active comparator | Procedure: Prone-Flexed PCNLProne-Flexed Position For Percutaneous Nephrolithotomy (PCNL) |
| Prone PCNL | Active comparator | Procedure: Prone PCNLProne Position For Percutaneous Nephrolithotomy (PCNL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Large renal pelvic stone
- Upper calyceal stone
- Middle calyceal stone
Key exclusion criteria (6 listed)
- lower calyceal stone
- 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-Flexed PCNLAlso: Prone-Flexed Percutaneous NephrolithotomyProne-Flexed Position For Percutaneous Nephrolithotomy (PCNL) | Procedure or surgery | Prone-Flexed PCNL |
| Prone PCNLAlso: Prone Percutaneous NephrolithotomyProne Position For Percutaneous Nephrolithotomy (PCNL) | Procedure or surgery | Prone PCNL |
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
2 secondary outcomes
Assessment of stone free rate (SFR) of the two groups
Time frame: 1 year
Asses the easiness of accessibility of the targeted stone
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 7 Jun 2017.
- Individual participant dataSharing planned: Yes. meta-analyses by contact the Prof. Ahmed Shoma, MD, Phd (Study Chair)
Related trials for Percutaneous Nephrolithotomy (PCNL)
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Nephrostomy Tract Infiltration for Pain Control After PCNL
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Tract Closure in PCNL
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Active, not recruitingObservational study
Reducing Opioid Prescription After Kidney Stone Removal Surgery
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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.
Ahmed Shoma, MD study chair
Urology and Nephrology center
Ahmed Elassmy, MD study director
Urology and Nephrology center
Nasr Eltabey, MD study director
Urology and Nephrology center
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-Flexed PCNL and Prone PCNL in people with Percutaneous Nephrolithotomy (PCNL) and Prone Position, run by Mansoura 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 3 inclusion and 6 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 7 Jun 2017. 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 Abdelwahab R. Hashem, Msc (01069678979 ext. 002, abdelwahab_hashem@yahoo.com), or a site near the patient. 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 7 Jun 2017.